Roche Diagnostics Operations (Rdo)
Medical device manufacturer in Indianapolis, IN.
14510(k) clearances
0PMA approvals
0recalls
Device types
- PDJ Hemoglobin A1c Test System 2
- DKB Calibrators, Drug Mixture 1
- JIQ Turbidimetric Method, Protein Or Albumin… 1
- LBR Ldl & Vldl Precipitation, Hdl 1
- KLT Enzyme Immunoassay, Carbamazepine 1
- LEH Radioimmunoassay, Vancomycin 1
- JHS Differential Rate Kinetic Method, Cpk Or… 1
- NDY Test, Cystatin C 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- DDG Transferrin, Antigen, Antiserum, Control 1
- JIF Enzymatic Method, Ammonia 1
- DCN System, Test, C-Reactive Protein 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | 03/26/2020SE |
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | 02/21/2020SE |
| K183517 | Ammonia IIJIF · Traditional | 02/08/2019SE |
| K182095 | Tina-quant Transferrin ver.2 (urine application)DDG · Traditional | 11/05/2018SE |
| K171080 | ALP IFCC Gen.2CJE · Special | 05/10/2017SE |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ · Traditional | 12/19/2016SE |
| K162593 | HDL-Cholesterol Gen.4LBS · Traditional | 10/19/2016SE |
| K161817 | Tina-quant Cystatin C Gen.2NDY · Special | 07/27/2016SE |
| K160570 | Creatine KinaseJHS · Traditional | 05/25/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | 01/08/2016SE |
| K151578 | Carbamazepine Gen 4KLT · Traditional | 10/22/2015SE |
| K143691 | LDLC3 LDL-Cholesterol Gen.3LBR · Traditional | 01/28/2015SE |
| K141925 | Total Protein Urine/Csf GEN.3JIQ · Special | 12/09/2014SE |
| K141928 | Cobas C Acetaminophen GEN.2 Assay, ACET2 CalibratorDKB · Traditional | 11/25/2014SE |