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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 K223478
Device Name VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin
Applicant
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Cherece L. Jones
Correspondent
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Cherece L. Jones
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received11/18/2022
Decision Date 02/16/2023
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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