510(k) K981931 ยท CGN Acid, Folic, Radioimmunoassay
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY
| Applicant | Roche Diagnostics/Boehringer Mannheim GmbH, Pleasanton CA, US |
| Decision | Substantially Equivalent, Aug 25, 1998 |
| Received | Jun 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981931
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.