# K922201: Coamate Protein C Chromogenic Assay

- Pathway: 510(k) (Traditional)
- Applicant: Chromogenix AB
- Decided: Dec 7, 1992 after 210 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023990: Chromocheck Protein C 25; Chromocheck Protein C 50 (2003), 1 descendant of its own
- K980875: IL Test Protein C (1998), 1 descendant of its own
- K062430: Hemosil Protein C (2006), 0 descendants of its own
- K050365: Biophen Protein C5, C2.5, Models 221205, 221202 (2005), 0 descendants of its own
- K050448: Chromopep PC, Chromopep at, Models 2.5 and 5 (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K922201
Methodology: https://510kreport.com/methodology