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FDA 510(k)

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

K-Number: K250789 · 2025-06-12

ApplicantThermo Fisher Scientific (Oxoid Ltd.)
Decision Date2025-06-12
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is a medical device manufactured by Thermo Fisher Scientific (Oxoid Ltd.). It received FDA 510(k) clearance on 2025-06-12 under approval number K250789. 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 Aztreonam/Avibactam Disc (30/20 µg) AZA50?

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Thermo Fisher Scientific (Oxoid Ltd.). The 510(k) number is K250789.

When was Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 approved by the FDA?

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 received FDA 510(k) clearance on 2025-06-12, under approval number K250789.

What company makes Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50?

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is manufactured by Thermo Fisher Scientific (Oxoid Ltd.).

What is the FDA product code for Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50?

The FDA product code for Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is JTN.

Other Devices by Thermo Fisher Scientific (Oxoid Ltd.)

K251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

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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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