510(k) K012386 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
ACTICLOT PROTEIN S, MODEL 843L
| Applicant | American Diagnostica, Inc., Greenwich CT, US |
| Decision | Substantially Equivalent, Sep 14, 2001 |
| Received | Jul 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012386
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.