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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 K032014
Device Name N LATEX IGM
Applicant
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact KATHLEEN A DRAY-LYONS
Correspondent
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact KATHLEEN A DRAY-LYONS
Regulation Number866.5510
Classification Product Code
CFN  
Date Received06/30/2003
Decision Date 08/07/2003
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
Recalls CDRH Recalls
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