# K974429: Rapet CRP

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Feb 18, 1998 after 86 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
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. The FDA summary names its predicate without a number.
- (no number) Pulse’s C-Reactive Protein Test: named in the summary without a submission number

## Indications for use
RaPET CRP (Class II) is intended for the qualitative and the semi-Quantitative detection of C-Reactive Protein (CRP) in human serum. The latex slide test is intended to be used as an aid in evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K974429
Methodology: https://510kreport.com/methodology