Roche Diagnostics Operations (Rdo)
FDA 510(k) medical device clearances.
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.