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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K133404
Device Name IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
Applicant
Phadia AB
4169 Commercial Ave.
Portae,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
Phadia AB
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5510
Classification Product Code
DGC  
Subsequent Product Code
JJX  
Date Received11/06/2013
Decision Date 02/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
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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