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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 K873355
Device Name MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
Applicant
Medix Biotech, Inc.
420 Lincoln Centre Dr.
Foster City,  CA  94404
Applicant Contact HUANG, PHD
Correspondent
Medix Biotech, Inc.
420 Lincoln Centre Dr.
Foster City,  CA  94404
Correspondent Contact HUANG, PHD
Regulation Number862.1625
Classification Product Code
CFT  
Date Received08/20/1987
Decision Date 10/09/1987
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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