510(k) K071319 ยท GGN Plasma, Coagulation Control
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
| Applicant | Bio-Rad, Diagnostics Grp., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 26, 2007 |
| Received | May 10, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071319
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.