510(k) K251968 ยท KQJ System, Fibrinogen Determination
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
| Applicant | Instrumentation Laboratory (IL) Co., Bedford MA, US |
| Decision | Substantially Equivalent, Jul 24, 2025 |
| Received | Jun 26, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251968
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.