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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, c-reactive protein
510(k) Number K061825
Device Name DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,,  DE  19714
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,,  DE  19714
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number866.5270
Classification Product Code
DCN  
Subsequent Product Codes
JIX   JJY  
Date Received06/28/2006
Decision Date 09/06/2006
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
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