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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K261853
Device Name Gepotidacin GEP 10 µg
Applicant
Liofilchem, Inc.
465 Waverley Oaks Rd.
Suite 317
Waltham,  MA  02452
Applicant Contact Emily Hodgkins
Correspondent
Liofilchem, Inc.
465 Waverley Oaks Rd.
Suite 317
Waltham,  MA  02452
Correspondent Contact Emily Hodgkins
Regulation Number866.1620
Classification Product Code
JTN  
Date Received06/03/2026
Decision Date 07/23/2026
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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