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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Thyroglobulin Autoantibody
510(k) Number K072661
Device Name IMMUNOCAP THYRLOBULIN IMMUNOCAP
Applicant
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5870
Classification Product Code
JNL  
Subsequent Product Codes
JJY   JZO  
Date Received09/21/2007
Decision Date 11/20/2007
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
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