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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 K920952
Device Name VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Applicant Contact CHERYL WINTERS-HEAD
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Correspondent Contact CHERYL WINTERS-HEAD
Regulation Number866.5340
Classification Product Code
DBF  
Date Received02/26/1992
Decision Date 04/07/1992
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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