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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Plate, Antifungal
510(k) Number K061945
Device Name VITEK 2 AST-YS FLUCONAZOLE
Applicant
bioMerieux, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2320
Applicant Contact Nancy Weaver
Correspondent
bioMerieux, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042 -2320
Correspondent Contact Nancy Weaver
Regulation Number866.1640
Classification Product Code
NGZ  
Date Received07/10/2006
Decision Date 09/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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