# K991224: K-Assay CRP

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: May 14, 1999 after 32 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
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
The K-ASSAY CRP Assay is intended to be used for the quantitative determination of CRP in serum by immunoturbidimetric assay. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K991224
Methodology: https://510kreport.com/methodology