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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 K914756
Device Name ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO 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 Number862.1690
Classification Product Code
JLW  
Date Received10/22/1991
Decision Date 01/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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