510(k) K892050 ยท GJS Test, Time, Prothrombin
HELENA THROMBOPLASTIN REAGENT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 7, 1989 |
| Received | Mar 29, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892050
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.