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510(k) K160724

ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator by Siemens Healthcare Diagnostics, Inc. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2016
Date Received
March 16, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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