# K971467: Synchron CX Systems Glucose Reagent (Glu)

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Liquid Chemistries Corp.
- Decided: Jun 16, 1997 after 55 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
Glucose Reagent is intended for the quantitative determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K971467
Methodology: https://510kreport.com/methodology