Roche Diagnostics Operations (Rdo)
14 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| Tina-quant Hemoglobin A1cDx Gen.3 (K193053) | Roche Diagnostics Operations (Rdo) | 2020-03-26 |
| Tina-quant C-Reactive Protein IV (K192072) | Roche Diagnostics Operations (Rdo) | 2020-02-21 |
| Ammonia II (K183517) | Roche Diagnostics Operations (Rdo) | 2019-02-08 |
| Tina-quant Transferrin ver.2 (urine application) (K182095) | Roche Diagnostics Operations (Rdo) | 2018-11-05 |
| ALP IFCC Gen.2 (K171080) | Roche Diagnostics Operations (Rdo) | 2017-05-10 |
| cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (K160571) | Roche Diagnostics Operations (Rdo) | 2016-12-19 |
| HDL-Cholesterol Gen.4 (K162593) | Roche Diagnostics Operations (Rdo) | 2016-10-19 |
| Tina-quant Cystatin C Gen.2 (K161817) | Roche Diagnostics Operations (Rdo) | 2016-07-27 |
| Creatine Kinase (K160570) | Roche Diagnostics Operations (Rdo) | 2016-05-25 |
| ONLINE TDM Vancomycin Gen.3 (K152245) | Roche Diagnostics Operations (Rdo) | 2016-01-08 |
| Carbamazepine Gen 4 (K151578) | Roche Diagnostics Operations (Rdo) | 2015-10-22 |
| LDLC3 LDL-Cholesterol Gen.3 (K143691) | Roche Diagnostics Operations (Rdo) | 2015-01-28 |
| TOTAL PROTEIN URINE/CSF GEN.3 (K141925) | Roche Diagnostics Operations (Rdo) | 2014-12-09 |
| COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (K141928) | Roche Diagnostics Operations (Rdo) | 2014-11-25 |
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Every clearance here is in the API, with alerts when new ones post.