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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 K232967
Device Name VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
Applicant
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Esther Hernandez
Correspondent
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Esther Hernandez
Regulation Number866.1640
Classification Product Code
NGZ  
Subsequent Product Codes
LON   LRG   LTT   LTW  
Date Received09/21/2023
Decision Date 06/12/2024
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
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