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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 K211136
Device Name VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
Applicant
BioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Esther Hernandez
Correspondent
BioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Esther Hernandez
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received04/16/2021
Decision Date 06/14/2021
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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