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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 K222430
Device Name VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
Applicant
bioMerieux SA, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Applicant Contact Craig Buehler
Correspondent
bioMerieux SA, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Correspondent Contact Craig Buehler
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received08/11/2022
Decision Date 03/09/2023
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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