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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antinuclear antibody (enzyme-labeled), antigen, controls
510(k) Number K083188
Device Name VARELISA RECOMBI ANA SCREEN, MODEL 12 596
Applicant
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5100
Classification Product Code
LJM  
Date Received10/29/2008
Decision Date 03/13/2009
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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