510(k) K920147 ยท GJA Test, Thrombin Time
THROMBIN CLOTTING TIME REAGENT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, May 1, 1992 |
| Received | Jan 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920147
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.