510(k) K031377 ยท GKP Instrument, Coagulation, Automated
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 8, 2003 |
| Received | May 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031377
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.