N350736

N350736 July 14, 2025 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification TARIFF NO.: 9027.89.4530; 9903.01.25; 9817.00.96 Samuel Finkelstein LMD Trade Law PLLC 1629 K Street NW, Suite 300 Washington, DC 20006 RE: The tariff classification of blood glucose monitoring systems from the Philippines and South Korea Dear Mr. Finkelstein: In your letter dated June 27, 2025, on behalf of your client, Arkray Factory USA, Inc., you requested a tariff classification ruling. Descriptive literature was provided for our review. The first item under consideration is the ReliOn Premier Compact Kit (part number 783110), which is a blood glucose monitoring system designed for individuals managing diabetes. In operation, the meter utilizes test strips which are inserted into the meter. A small blood sample is applied to the test strip. The meter then uses a chemical reaction on the test strip to determine the glucose concentration in the blood sample before displaying on the screen. The system includes the meter, carrying case, owner’s guide, test strips, a lancing device, and lancets, and is produced in the Philippines. The second item under consideration is the Glucocard Shine Express Kit (part number 544110), which is a blood glucose monitoring system designed for individuals managing diabetes. In operation, the meter utilizes test strips which are inserted into the meter. A small blood sample is applied to the test strip. The meter then uses a chemical reaction on the test strip to determine the glucose concentration in the blood sample before displaying on the screen. This meter also contains 29 different voice prompts helping the user through meter set-up, testing and review of results in their choice of English or Spanish. The system includes the meter, carrying case, owner’s guide, test strips, a lancing device, lancets, and a control solution, and is produced in South Korea. General Rule of Interpretation (GRI) 1, Harmonized Tariff Schedule of the United States (HTSUS), states in part that for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes. Goods that are, prima facie, classifiable under two or more headings, are classifiable in accordance with GRI 3, HTSUS. GRI 3(a) states, in part, that when two or more headings each refer to a part of the items in a set put up for retail sale, those headings are to be regarded as equally specific, even if one heading gives a more precise description of the good. The instant goods consist of at least two different articles that are, prima facie, classifiable in different subheadings. It consists of articles put up together to carry out a specific activity (i.e., blood glucose testing). Finally, the articles are put up in a manner suitable for sale directly to users without repacking. Therefore, the goods in question are within the term “goods put up in sets for retail sale.” GRI 3(b) states, in part, that goods put up in sets for retail sale, which cannot be classified by reference to GRI 3(a), are to be classified as if they consisted of the component which gives them their essential character. It is the opinion of this office that the essential character of the glucose meter kits when imported with the meter, manual, carrying case, lancets, lancing device and test strips, is imparted by the glucose meter. In your letter you suggest the applicable subheading for the glucose meter kits to be 9027.50.8015, HTSUS, which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other: Other: Chemical analysis instruments and apparatus.” We disagree. Each of the glucose monitoring devices use an electro-chemical process creating a current to provide the readings. There are no optical elements present in the meters. Therefore, subheading 9027.50, HTSUS, is not applicable. Accordingly, the applicable subheading for the ReliOn Premier Compact Kit (part number 783110) and the Glucocard Shine Express Kit (part number 544110) will be 9027.89.4530, HTSUS, which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus: Other: Other: Electrical: Chemical analysis instruments and apparatus.” The general rate of duty will be free. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading 9027.89.4530, HTSUS, listed above. In your letter, you also requested consideration of a secondary classification for the subject ReliOn Premier Compact Kit and the Glucocard Shine Express Kit under 9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Chapter 98, Subchapter XVII, U.S. Note 4(a), HTSUS, defines the term blind or other physically or mentally handicapped persons as including “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for oneself, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” We note that in Headquarters Ruling (HQ) 561020 (dated October 14, 1998), Customs and Border Protection (CBP) held that people with diabetes suffer from a permanent or physical impairment within the meaning of U.S. Note 4(a) to Chapter 98 of the HTSUS. In HQ 562869 (dated December 23, 2003), CBP held that a pump designed for individuals suffering from diabetes or glucose control problems was an article specifically designed or adapted for the handicapped and is properly classified under 9817.00.96 for secondary classification purposes. In New York Ruling N292225 (dated December 18, 2017), CBP held that Insulet’s Insulin Delivery Omnipod was classified under 9817.00.96 for secondary classification purposes. Additionally, as discussed in HQ 964169 (dated June 26, 2001), “people with diabetes are limited in their ability to perform a broad range of jobs because they must be able to monitor their blood sugar, inject insulin if prescribed, and have work restrictions due to excessive urination, possible nausea, dizziness and fainting. This interferes with working, a major life activity. Therefore, persons with diabetes suffer from a permanent or chronic physical impairment which substantially limits a major life activity and therefore, are considered physically handicapped persons under U.S. Note 4(a).” The ReliOn Premier Compact Kit and the Glucocard Shine Express Kit perform a chemical analysis on a diabetic’s blood sample to determine if their levels are too high or too low, which is a direct link to the physical impairment. Accordingly, based on the info

(for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus using optical radiations (ultraviolet, visible, infrared): Other: Other: Chemical analysis instruments and apparatus.” We disagree. Each of the glucose monitoring devices use an electro-chemical process creating a current to provide the readings. There are no optical elements present in the meters. Therefore, subheading 9027.50, HTSUS, is not applicable. Accordingly, the applicable subheading for the ReliOn Premier Compact Kit (part number 783110) and the Glucocard Shine Express Kit (part number 544110) will be 9027.89.4530, HTSUS, which provides for “Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes; parts and accessories thereof: Other instruments and apparatus: Other: Other: Electrical: Chemical analysis instruments and apparatus.” The general rate of duty will be free. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your produc