510(k) K063679 ยท GKP Instrument, Coagulation, Automated
ACL TOP
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jan 12, 2007 |
| Received | Dec 11, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2007 | Instrumentation Laboratory Co. Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer.
P/N 280000 Terminated |
GKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.