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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 K081731
Device Name DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
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 Codes
JHS   JIX  
Date Received06/19/2008
Decision Date 08/29/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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