510(k) K000528 ยท GIR Reagent, Russel Viper Venom
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Apr 7, 2000 |
| Received | Feb 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000528
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.