# K030044: Extended Range HS CRP Kit, Cat NO:9200

- Pathway: 510(k) (Traditional)
- Applicant: Reference Diagnostics, Inc.
- Decided: Sep 30, 2003 after 267 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
For in vitro diagnostic use only. The RDI Extended Range hs CRP Kit is for the quantitative determination of C-reactive protein in human serum or plasma by immunoturbidimetric measurement.

Source page: https://510kreport.com/device/K030044
Methodology: https://510kreport.com/methodology