510(k) K160571 ยท PDJ Hemoglobin A1c Test System
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 19, 2016 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2019 | Roche Diagnostics Operations, Inc. cobas c513 Analyzer Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.