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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 K220805
Device Name VITEK 2 AST-Gram Positive Cefoxitin Screen
Applicant
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Debra Broyles
Correspondent
bioMerieux, Inc
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Nathan Hardesty
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received03/18/2022
Decision Date 10/13/2022
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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