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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K961236
Device Name UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
Applicant
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041 -1517
Applicant Contact WUAN T LU
Correspondent
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041 -1517
Correspondent Contact WUAN T LU
Regulation Number862.1710
Classification Product Code
CDP  
Date Received03/29/1996
Decision Date 05/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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