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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nad reduction/nadh oxidation, cpk or isoenzymes
510(k) Number K160724
Device Name ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DRIVE
NEWARK,  DE  19714
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DRIVE
NEWARK,  DE  19714
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number862.1215
Classification Product Code
CGS  
Subsequent Product Code
JIT  
Date Received03/16/2016
Decision Date 09/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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