510(k) K193053 ยท PDJ Hemoglobin A1c Test System
Tina-quant Hemoglobin A1cDx Gen.3
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 26, 2020 |
| Received | Nov 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193053
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.