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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 K210287
Device Name VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
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  
Date Received02/02/2021
Decision Date 10/28/2021
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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