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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name method, nephelometric, immunoglobulins (g, a, m)
510(k) Number K081161
Device Name DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
Applicant
DADE BEHRING, INC.
500 GBC DR, MAILSTOP 514
NEWARK,  DE  19714 -6101
Applicant Contact HELEN M LEE
Correspondent
DADE BEHRING, INC.
500 GBC DR, MAILSTOP 514
NEWARK,  DE  19714 -6101
Correspondent Contact HELEN M LEE
Regulation Number866.5510
Classification Product Code
CFN  
Subsequent Product Codes
JIX   JJY  
Date Received04/24/2008
Decision Date 07/28/2008
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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