# K970664: Glucose Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Derma Media Lab., Inc.
- Decided: Aug 1, 1997 after 161 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K112377: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer (2012), 1 descendant of its own
- K140690: BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer (2014), 0 descendants of its own

## Indications for use
The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.

Source page: https://510kreport.com/device/K970664
Methodology: https://510kreport.com/methodology