510(k) K802117 ยท GJA Test, Thrombin Time
FIBRI QUIK
| Applicant | General Diagnostics, Walker MI, US |
| Decision | Substantially Equivalent, Sep 26, 1980 |
| Received | Sep 4, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2004 | bioMerieux MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969 Terminated |
GJA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.