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FDA 510(k)

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

K-Number: K251337 · 2025-12-05

ApplicantThermo Fisher Scientific (Oxoid Ltd.)
Decision Date2025-12-05
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific (Oxoid Ltd.). It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K251337. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10?

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Thermo Fisher Scientific (Oxoid Ltd.). The 510(k) number is K251337.

When did Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 received FDA 510(k) clearance on 2025-12-05, under 510(k) number K251337.

Who is the listed applicant for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10?

The FDA 510(k) record lists Thermo Fisher Scientific (Oxoid Ltd.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10?

The FDA product code for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is JTN.

Other records listing Thermo Fisher Scientific (Oxoid Ltd.) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60K250789Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

Related Devices (Code: JTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy DiagnosticsK251879Sulopenem SPM 2 µgLiofilchemK250956HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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