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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K896641
Device Name MODIFIED PROLACTIN 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 Number862.1625
Classification Product Code
CFT  
Date Received11/24/1989
Decision Date 12/27/1989
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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