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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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