# K023990: Chromocheck Protein C 25; Chromocheck Protein C 50

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Mar 19, 2003 after 106 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- 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 K922201 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922201: Coamate Protein C Chromogenic Assay, Chromogenix AB (1992) Summary page 2.

## Most influential descendants
- K050448: Chromopep PC, Chromopep at, Models 2.5 and 5 (2005), 0 descendants of its own

## Indications for use
ChromoCheckTMProtein C is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.

Source page: https://510kreport.com/device/K023990
Methodology: https://510kreport.com/methodology