510(k) K001645 ยท GKP Instrument, Coagulation, Automated
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
| Applicant | Dade Behring, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Aug 4, 2000 |
| Received | May 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001645
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.