510(k) K965113 ยท KQJ System, Fibrinogen Determination
N-ASSAY TIA FIBRINOGEN TEST KIT
| Applicant | Crestat Diagnostics, Inc., Weston CT, US |
| Decision | Substantially Equivalent, Apr 16, 1997 |
| Received | Dec 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965113
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.