510(k) K103716 ยท CGN Acid, Folic, Radioimmunoassay
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 12, 2011 |
| Received | Dec 21, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103716
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.