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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myeloperoxidase, Immunoassay, System, Test
510(k) Number K071474
Device Name DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
Applicant
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714
Applicant Contact GEORGE M PLUMMER
Correspondent
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact GEORGE M PLUMMER
Regulation Number866.5600
Classification Product Code
NTV  
Subsequent Product Codes
JIT   JJX  
Date Received05/29/2007
Decision Date 12/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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
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