510(k) K940490 ยท GIR Reagent, Russel Viper Venom
DV TEST AND DVV CONFIRM
| Applicant | American Diagnostica, Inc., Greenwich CT, US |
| Decision | Substantially Equivalent, Apr 5, 1995 |
| Received | Feb 3, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940490
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.