510(k) K934210 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 22, 1994 |
| Received | Aug 30, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934210
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.