510(k) K935748 ยท GJS Test, Time, Prothrombin
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 26, 1995 |
| Received | Dec 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935748
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.