510(k) K060688 ยท GFO Activated Partial Thromboplastin
HEMOSIL SYNTHASIL
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Apr 13, 2006 |
| Received | Mar 15, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060688
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2026 | Instrumentation Laboratory The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of
heparin therapy. Open, Classified |
GFO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.