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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, Thyroid Autoantibody
510(k) Number K090760
Device Name THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
Applicant
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Applicant Contact GABRIELLA LAKOS
Correspondent
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Correspondent Contact GABRIELLA LAKOS
Regulation Number866.5870
Classification Product Code
JZO  
Date Received03/23/2009
Decision Date 09/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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