510(k) K002400 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
MODIFICATION OF ACL ADVANCE
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Aug 30, 2000 |
| Received | Aug 4, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002400
| 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 Advance 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.