# K991372: CRP

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 1, 1999 after 42 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: 1 generation back to K930621 (1993). 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)
- K930621: Tina-Quant CRP, Boehringer Mannheim Corp. (1993) Summary page 1.

## Indications for use
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum and plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K991372
Methodology: https://510kreport.com/methodology