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510(k) K251337

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 by Thermo Fisher Scientific (Oxoid Ltd.) — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2025
Date Received
April 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

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