510(k) K922326 ยท GIR Reagent, Russel Viper Venom
LUPO-TEST REGEANT
| Applicant | Graoipore , Ltd., Pyrmont 2009 Australia, AU |
| Decision | Substantially Equivalent, Apr 6, 1993 |
| Received | May 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922326
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.