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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 K131738
Device Name IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
Applicant
Phadia AB
Rapsgatan 7
P.O. Box 6460
Uppsala,  SE SE - 75137
Applicant Contact CARINA MAGNUSSON
Correspondent
Phadia AB
Rapsgatan 7
P.O. Box 6460
Uppsala,  SE SE - 75137
Correspondent Contact CARINA MAGNUSSON
Regulation Number866.5750
Classification Product Code
DHB  
Date Received06/13/2013
Decision Date 07/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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