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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 K260281
Device Name VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
Applicant
BIOMERIEUX
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Neal Bertels
Correspondent
BIOMERIEUX
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Neal Bertels
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received01/29/2026
Decision Date 03/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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