Roche Diagnostics Operations (Rdo)
Roche Diagnostics Operations (Rdo) holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2020.
Top product codes for Roche Diagnostics Operations (Rdo)
Recent clearances by Roche Diagnostics Operations (Rdo)
- K193053 — Tina-quant Hemoglobin A1cDx Gen.3
- K192072 — Tina-quant C-Reactive Protein IV
- K183517 — Ammonia II
- K182095 — Tina-quant Transferrin ver.2 (urine application)
- K171080 — ALP IFCC Gen.2
- K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
- K162593 — HDL-Cholesterol Gen.4
- K161817 — Tina-quant Cystatin C Gen.2
- K160570 — Creatine Kinase
- K152245 — ONLINE TDM Vancomycin Gen.3
- K151578 — Carbamazepine Gen 4
- K143691 — LDLC3 LDL-Cholesterol Gen.3
- K141925 — TOTAL PROTEIN URINE/CSF GEN.3
- K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.