510(k) K082091 ยท GKZ Counter, Differential Cell
TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
| Applicant | Reametrix, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Apr 15, 2009 |
| Received | Jul 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082091
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.