# K971908: Crea or Creatinine

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Liquid Chemistries Corp.
- Decided: Jun 17, 1997 after 25 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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
Creatinine Reagent is intended for the quantitative determination of serum creatinine using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of renal malfunction.

Source page: https://510kreport.com/device/K971908
Methodology: https://510kreport.com/methodology