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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 K193572
Device Name VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
Applicant
Biomerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Jolyn Tenllado
Correspondent
Biomerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Jolyn Tenllado
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received12/23/2019
Decision Date 03/13/2020
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
Predetermined Change
Control Plan Authorized		 No
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