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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K962211
Device Name UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
Applicant
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041
Applicant Contact WUAN T LU
Correspondent
United Biotech, Inc.
110 Pioneer Way, #C
Mountain View,  CA  94041
Correspondent Contact WUAN T LU
Regulation Number862.1700
Classification Product Code
KLI  
Date Received06/10/1996
Decision Date 07/08/1996
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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