510(k) K033414 ยท GKP Instrument, Coagulation, Automated
ACL TOP MODEL, TOP
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jan 12, 2004 |
| Received | Oct 27, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K033414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2005 | Instrumentation Laboratory Co. ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.