510(k) K951891 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
ACL FUTURA COAGULATION SYSTEM
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Nov 3, 1995 |
| Received | Apr 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951891
| 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 |
| Jul 20, 2004 | Instrumentation Laboratory Co. ACL Futura Instrument Analyzer Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.