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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Gliadin
510(k) Number K052793
Device Name IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02
Applicant
Pharmacia Diagnostics AB
4169 Commercial Ave.
Portae,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
Pharmacia Diagnostics AB
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5750
Classification Product Code
MST  
Date Received10/03/2005
Decision Date 02/07/2006
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
Predetermined Change
Control Plan Authorized		 No
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