# K990981: Glucose,  Hexokinase (R1), Model GL101-01, Glucose Hexokinase (R2), Model GL101-02

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: May 25, 1999 after 63 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The glucose hexokinase reagents are intended for in vitro diagnostic use in the quantitative determination of glucose in serum, plasma, urine and CSF.

Source page: https://510kreport.com/device/K990981
Methodology: https://510kreport.com/methodology