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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, radioallergosorbent (rast) immunological
510(k) Number K122197
Device Name AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
Original Applicant
PHADIA US INC.
4169 commercial ave.
portage,  MI  49002
Original Contact martin mann
Regulation Number866.5750
Classification Product Code
DHB  
Date Received07/24/2012
Decision Date 08/28/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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