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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K920661
Device Name VIDAS CMV IGG ASSAY
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received02/13/1992
Decision Date 02/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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