# K040987: Cryocheck Clot C

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic, Inc.
- Decided: Jun 18, 2004 after 64 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 K861079 (1986). 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)
- K861079: Staclot Protein C Test Kit, American Bioproducts Co. (1986) Summary page 1.

## Indications for use
CryoCheck Clot C is a clot-based assay intended for the quantitative determination of protein C activity in citrated human plasma.

Source page: https://510kreport.com/device/K040987
Methodology: https://510kreport.com/methodology