510(k) K010350 ยท GGN Plasma, Coagulation Control
STA -CALIBRATOR HBPM/LMWH KIT
| Applicant | Diagnostica Stago, Inc., Parisppany NJ, US |
| Decision | Substantially Equivalent, Apr 9, 2001 |
| Received | Feb 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010350
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.