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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test,Alpha-Fetoprotein For Testicular Cancer
510(k) Number K071597
Device Name DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number866.6010
Classification Product Code
LOJ  
Subsequent Product Code
JIX  
Date Received06/12/2007
Decision Date 06/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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