510(k) K073377 ยท GKP Instrument, Coagulation, Automated
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, May 4, 2008 |
| Received | Dec 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073377
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.