510(k) K953981 ยท GFO Activated Partial Thromboplastin
SYNTHASIL APTT REAGENT
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Nov 30, 1995 |
| Received | Aug 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953981
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.