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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 K897144
Device Name THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
Applicant
Medix Biotech, Inc.
420 Lincoln Centre Dr.
Foster City,  CA  94404
Applicant Contact CHEN, PH.D.
Correspondent
Medix Biotech, Inc.
420 Lincoln Centre Dr.
Foster City,  CA  94404
Correspondent Contact CHEN, PH.D.
Regulation Number862.1700
Classification Product Code
KLI  
Date Received12/27/1989
Decision Date 03/15/1990
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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