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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apolipoproteins
510(k) Number K063608
Device Name DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND 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 Number862.1475
Classification Product Code
MSJ  
Subsequent Product Codes
JIX   JJY  
Date Received12/04/2006
Decision Date 02/23/2007
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
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