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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name alpha-2-macroglobulin, antigen, antiserum, control
510(k) Number K081249
Device Name DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
Applicant
DADE BEHRING, INC.
500 GBC DR, MAILSTOP 514
NEWARK,  DE  19714 -6101
Applicant Contact ANNA MARIE KATHLEEN ENNIS
Correspondent
DADE BEHRING, INC.
500 GBC DR, MAILSTOP 514
NEWARK,  DE  19714 -6101
Correspondent Contact ANNA MARIE KATHLEEN ENNIS
Regulation Number866.5620
Classification Product Code
DEB  
Subsequent Product Codes
JIX   JJY  
Date Received05/02/2008
Decision Date 07/21/2008
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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