510(k) K891370 ยท GJS Test, Time, Prothrombin
EDL ONE-STAGE PROTHROMBIN TIME REAGENT
| Applicant | Elite Diagnostic , Ltd., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 21, 1989 |
| Received | Mar 9, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891370
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.