510(k) K132828 ยท JKR Radioimmunoassay, Calcitonin
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 4, 2013 |
| Received | Sep 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132828
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.