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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioassay, vitamin b12
510(k) Number K071224
Device Name DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
CGN   JIX  
Date Received05/02/2007
Decision Date 11/13/2007
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
Recalls CDRH Recalls
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