510(k) K843535 ยท GJS Test, Time, Prothrombin
ORTHO BRAIN THROMBOPLASTIN DILUENT
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 12, 1984 |
| Received | Sep 7, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843535
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.