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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 K251337
Device Name Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
Applicant
Thermo Fisher Scientific (Oxoid Ltd.)
Wade Rd.
Basingstoke,  GB RG24 8PW
Applicant Contact Sonali Karnik
Correspondent
Thermo Fisher Scientific (Oxoid Ltd.)
Wade Rd.
Basingstoke,  GB RG24 8PW
Correspondent Contact Shilpa Bhalerao
Regulation Number866.1620
Classification Product Code
JTN  
Date Received04/30/2025
Decision Date 12/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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