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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 K200590
Device Name VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Cherece L. Jones
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Cherece L. Jones
Regulation Number866.1645
Classification Product Code
Subsequent Product Codes
Date Received03/06/2020
Decision Date 04/28/2020
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