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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 K133817
Device Name VITEK 2 AST - YEAST FLUCONAZOLE
Applicant
bioMerieux, Inc.
100 Rodolphe St.
Durham,  NC  27712
Applicant Contact JOCELYN JENNINGS
Correspondent
bioMerieux, Inc.
100 Rodolphe St.
Durham,  NC  27712
Correspondent Contact JOCELYN JENNINGS
Regulation Number866.1640
Classification Product Code
NGZ  
Date Received12/16/2013
Decision Date 08/05/2014
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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