# K974050: Synchron Systems C-Reactive Protein (CRP) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Nov 24, 1997 after 31 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963061 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963061: Immage Immunochemistry System C-Reactive Protein (CRP) Reagent, Beckman Instruments, Inc. (1996) Summary page 1.

## Indications for use
The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent, in conjunction with the SYNCHRON CX® CRP Calibrator Set, is intended for the quantitative determination of C-reactive protein concentration in serum or plasma.

Source page: https://510kreport.com/device/K974050
Methodology: https://510kreport.com/methodology