# K990825: Revised C-Reactive Protein (RCRP) Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 16, 1999 after 35 days
- Product code: DCN (System, Test, C-Reactive Protein)
- 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: 2 generations back to K860894 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962523: N Latex CRP Mono Reagent, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure C-reactive protein in human serum and plasma. Measurements of C-reactive protein are used in the evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K990825
Methodology: https://510kreport.com/methodology