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Roche Diagnostics Operations (Rdo)

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories9
Latest FDA decision2020-03-26
TypeNumberDevice NameCodeDateActions
510(k) K193053 Tina-quant Hemoglobin A1cDx Gen.3PDJ2020-03-26 View
510(k) K192072 Tina-quant C-Reactive Protein IVDCN2020-02-21 View
510(k) K183517 Ammonia IIJIF2019-02-08 View
510(k) K182095 Tina-quant Transferrin ver.2 (urine application)DDG2018-11-05 View
510(k) K171080 ALP IFCC Gen.2CJE2017-05-10 View
510(k) K160571 cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ2016-12-19 View
510(k) K162593 HDL-Cholesterol Gen.4LBS2016-10-19 View
510(k) K161817 Tina-quant Cystatin C Gen.2NDY2016-07-27 View
510(k) K160570 Creatine KinaseJHS2016-05-25 View
510(k) K152245 ONLINE TDM Vancomycin Gen.3LEH2016-01-08 View
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