510(k) K051292 ยท CGN Acid, Folic, Radioimmunoassay
ELECSYS RBC FOLATE HEMOLYZED REAGENT
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 17, 2005 |
| Received | May 18, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051292
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.