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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 K083465
Device Name DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact VICTOR M CARRIO
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact VICTOR M CARRIO
Regulation Number862.1215
Classification Product Code
CGS  
Subsequent Product Code
JHS  
Date Received11/24/2008
Decision Date 02/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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