510(k) K121610 ยท PDJ Hemoglobin A1c Test System
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
| Applicant | Roche Diagnostics Operations, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 8, 2013 |
| Received | Jun 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121610
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.