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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K896642
Device Name MODIFIED LH 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 Number862.1485
Classification Product Code
CEP  
Date Received11/24/1989
Decision Date 01/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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