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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K030912
Device Name THYRO TEST
Applicant
THRYOTEC
163 CABOT STREET
BEVERLY,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
THRYOTEC
163 CABOT STREET
BEVERLY,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number862.1690
Classification Product Code
JLW  
Date Received03/24/2003
Decision Date 07/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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