Roche Diagnostics Operations (Rdo)
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories9
Latest Approval2020-03-26
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | PDJ | 2020-03-26 | View |
| 510(k) | K192072 | Tina-quant C-Reactive Protein IV | DCN | 2020-02-21 | View |
| 510(k) | K183517 | Ammonia II | JIF | 2019-02-08 | View |
| 510(k) | K182095 | Tina-quant Transferrin ver.2 (urine application) | DDG | 2018-11-05 | View |
| 510(k) | K171080 | ALP IFCC Gen.2 | CJE | 2017-05-10 | View |
| 510(k) | K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | PDJ | 2016-12-19 | View |
| 510(k) | K162593 | HDL-Cholesterol Gen.4 | LBS | 2016-10-19 | View |
| 510(k) | K161817 | Tina-quant Cystatin C Gen.2 | NDY | 2016-07-27 | View |
| 510(k) | K160570 | Creatine Kinase | JHS | 2016-05-25 | View |
| 510(k) | K152245 | ONLINE TDM Vancomycin Gen.3 | LEH | 2016-01-08 | View |
No matching devices.