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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K920046
Device Name MODIFIED FERRITIN ENZYME IMUNOASSAY 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 Number866.5340
Classification Product Code
DBF  
Date Received01/06/1992
Decision Date 01/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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