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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 K925436
Device Name MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
Applicant
MEDIX BIOTECH, INC.
420 LINCOLN CENTRE DR.
FOSTER CITY,  CA  94404
Applicant Contact JOHN CHEN
Correspondent
MEDIX BIOTECH, INC.
420 LINCOLN CENTRE DR.
FOSTER CITY,  CA  94404
Correspondent Contact JOHN CHEN
Regulation Number862.1710
Classification Product Code
CDP  
Date Received10/28/1992
Decision Date 12/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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