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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay (Two-Site Solid Phase), Ferritin
510(k) Number K873730
Device Name MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY 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 Number866.5340
Classification Product Code
JMG  
Date Received09/15/1987
Decision Date 11/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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