# K021882: Crpex-HS CRP Calibrator Set, Catalog NO: 1510

- Pathway: 510(k) (Traditional)
- Applicant: Good Biotech Corp.
- Decided: Jul 11, 2002 after 34 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 K003342 (2001). 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)
- K003342: Wako CRP-UL, CRP-UL Calibrator Set, Wako Chemicals USA, Inc. (2001)

## Indications for use
Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) in serum samples.

Source page: https://510kreport.com/device/K021882
Methodology: https://510kreport.com/methodology