# K960084: Hichem Glucose/HK Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hi Chem, Inc.
- Decided: Apr 4, 1996 after 84 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BMD Glucose/HK Reagent, product no. 704035: named in the summary without a submission number
- (no number) Sigma Glucose (HK) Reagent, procedure no. 16-UV: named in the summary without a submission number

## Indications for use
HiChem Glucose/HK Reagent (product no. 70007) is for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid and urine.

Source page: https://510kreport.com/device/K960084
Methodology: https://510kreport.com/methodology