FDA 510(k) Applications Submitted by ROCHE DIAGNOSTICS OPERATIONS (RDO)

FDA 510(k) Number Submission Date Device Name Applicant
K152245 08/10/2015 ONLINE TDM Vancomycin Gen.3 ROCHE DIAGNOSTICS OPERATIONS (RDO)
K162593 09/16/2016 HDL-Cholesterol Gen.4 Roche Diagnostics Operations (RDO)
K192072 08/02/2019 Tina-quant C-Reactive Protein IV Roche Diagnostics Operations (RDO)
K160571 02/29/2016 cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay Roche Diagnostics Operations (RDO)
K151578 06/11/2015 Carbamazepine Gen 4 Roche Diagnostics Operations (RDO)
K193053 11/01/2019 Tina-quant Hemoglobin A1cDx Gen.3 Roche Diagnostics Operations (RDO)
K182095 08/03/2018 Tina-quant Transferrin ver.2 (urine application) Roche Diagnostics Operations (RDO)
K143691 12/24/2014 LDLC3 LDL-Cholesterol Gen.3 Roche Diagnostics Operations (RDO)
K160570 02/29/2016 Creatine Kinase Roche Diagnostics Operations (RDO)
K183517 12/18/2018 Ammonia II Roche Diagnostics Operations (RDO)
K141928 07/16/2014 COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR Roche Diagnostics Operations (RDO)
K171080 04/11/2017 ALP IFCC Gen.2 Roche Diagnostics Operations (RDO)
K161817 07/01/2016 Tina-quant Cystatin C Gen.2 Roche Diagnostics Operations (RDO)
K141925 07/16/2014 TOTAL PROTEIN URINE/CSF GEN.3 Roche Diagnostics Operations (RDO)


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