FDA 510(k) Applications Submitted by Noel B. Mencias

FDA 510(k) Number Submission Date Device Name Applicant
K220134 01/18/2022 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH Roche Diagnostics
K143691 12/24/2014 LDLC3 LDL-Cholesterol Gen.3 Roche Diagnostics Operations (RDO)
K160570 02/29/2016 Creatine Kinase Roche Diagnostics Operations (RDO)
K162526 09/09/2016 Creatine Kinase-MB ROCHE DIAGNOSTICS
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)


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