510(k) K905857 ยท GJS Test, Time, Prothrombin
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Feb 27, 1991 |
| Received | Dec 14, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905857
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.