Company ยท US
Roche Diagnostics Operations (Rdo)
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2020. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PDJ | Hemoglobin A1c Test System | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DKB | Calibrators, Drug Mixture | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| JIF | Enzymatic Method, Ammonia | 1 |
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| LEH | Radioimmunoassay, Vancomycin | 1 |
| NDY | Test, Cystatin C | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2020 | K193053 | Tina-quant Hemoglobin A1cDx Gen.3 Roche Diagnostics Operations (Rdo) | PDJ |
| Feb 21, 2020 | K192072 | Tina-quant C-Reactive Protein IV Roche Diagnostics Operations (Rdo) | DCN |
| Feb 8, 2019 | K183517 | Ammonia II Roche Diagnostics Operations (Rdo) | JIF |
| Nov 5, 2018 | K182095 | Tina-quant Transferrin ver.2 (urine application) Roche Diagnostics Operations (Rdo) | DDG |
| May 10, 2017 | K171080 | ALP IFCC Gen.2 Roche Diagnostics Operations (Rdo) | CJE |
| Dec 19, 2016 | K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay Roche Diagnostics Operations (Rdo) | PDJ |
| Oct 19, 2016 | K162593 | HDL-Cholesterol Gen.4 Roche Diagnostics Operations (Rdo) | LBS |
| Jul 27, 2016 | K161817 | Tina-quant Cystatin C Gen.2 Roche Diagnostics Operations (Rdo) | NDY |
| May 25, 2016 | K160570 | Creatine Kinase Roche Diagnostics Operations (Rdo) | JHS |
| Jan 8, 2016 | K152245 | ONLINE TDM Vancomycin Gen.3 Roche Diagnostics Operations (Rdo) | LEH |
| Oct 22, 2015 | K151578 | Carbamazepine Gen 4 Roche Diagnostics Operations (Rdo) | KLT |
| Jan 28, 2015 | K143691 | LDLC3 LDL-Cholesterol Gen.3 Roche Diagnostics Operations (Rdo) | LBR |
| Dec 9, 2014 | K141925 | TOTAL PROTEIN URINE/CSF GEN.3 Roche Diagnostics Operations (Rdo) | JIQ |
| Nov 25, 2014 | K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR Roche Diagnostics Operations (Rdo) | DKB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||