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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K260696
Device Name MTS Gepotidacin 0.016-256 µg/mL
Applicant
Liofilchem s.r.l.
Via Scozia, Zona Industriale
64026
Roseto Degli Abruzzi,  IT
Applicant Contact Fabio Brocco
Correspondent
Laboratory Specialists, Inc.
26214 Center Ridge Rd.
Westlake,  OH  44145
Correspondent Contact Laura Koeth
Regulation Number866.1640
Classification Product Code
JWY  
Date Received03/03/2026
Decision Date 04/17/2026
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		 Yes
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