510(k) K253957 ยท GFO Activated Partial Thromboplastin
HemosIL Silica Clotting Time
| Applicant | Instrumentation Laboratory (IL) Co., Bedford MA, US |
| Decision | Substantially Equivalent, Jan 9, 2026 |
| Received | Dec 10, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253957
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.