510(k) K940310 ยท GJS Test, Time, Prothrombin
HELENA THROMBOPLASTIN-MI REAGENT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Apr 20, 1994 |
| Received | Jan 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940310
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.