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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 a medical device manufactured by Thermo Fisher Scientific (Oxoid Ltd.). It received FDA 510(k) clearance on 2025-12-05 under approval 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. It is manufactured by Thermo Fisher Scientific (Oxoid Ltd.). The 510(k) number is K251337.

When was Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 approved by the FDA?

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

What company makes Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10?

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is manufactured by Thermo Fisher Scientific (Oxoid Ltd.).

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 Devices by Thermo Fisher Scientific (Oxoid Ltd.)

K250789Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

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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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