Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10— 510(k) K251337

Name: FDA 510(k) clearance K251337
Creator: U.S. Food and Drug Administration
Published: 2025-12-05

Substantially Equivalent

Thermo Fisher Scientific (Oxoid Ltd.)

FDA 510(k) clearance K251337 for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10, Substantially Equivalent on 2025-12-05. Applicant: Thermo Fisher Scientific (Oxoid Ltd.). Device class: 2.

Clearance details

Applicant: Thermo Fisher Scientific (Oxoid Ltd.)
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 2025-04-30
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

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