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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
510(k) Number K213241
Device Name VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
Applicant
BioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Applicant Contact Esther Hernandez
Correspondent
BioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Correspondent Contact Esther Hernandez
Regulation Number866.1645
Classification Product Code
LON  
Date Received09/30/2021
Decision Date 02/25/2022
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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