510(k) K082340 ยท CGN Acid, Folic, Radioimmunoassay
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 19, 2009 |
| Received | Aug 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082340
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.