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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, Mumps Virus
510(k) Number K923903
Device Name VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
Applicant
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number866.3380
Classification Product Code
LJY  
Date Received08/04/1992
Decision Date 08/09/1993
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
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