510(k) K961991 ยท GKP Instrument, Coagulation, Automated
ACL 6000 SYSTEM (ACL 6000)
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Sep 4, 1996 |
| Received | May 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961991
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.