510(k) K955638 ยท GFO Activated Partial Thromboplastin
SYNTHAFAX APTT REAGENT
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Apr 23, 1996 |
| Received | Dec 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2025 | Instrumentation Laboratory HemosIL SynthAFax. Partial Thromboplastin Time Tests. Open, Classified |
GFO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.