510(k) K050365 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
| Applicant | Hyphen Biomed, Mason OH, US |
| Decision | Substantially Equivalent, Dec 27, 2005 |
| Received | Feb 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2023 | Aniara Diagnostica LLC BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein Open, Classified |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.