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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name complement c3, antigen, antiserum, control
510(k) Number K061852
Device Name DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, 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 Number866.5240
Classification Product Code
CZW  
Subsequent Product Codes
DBI   JIX   JJY  
Date Received06/30/2006
Decision Date 09/22/2006
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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