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FDA 510(k)

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5

K-Number: K231806 · 2024-03-22

ApplicantOxoid Limited (Part of Thermo Fisher Scientific)
Decision Date2024-03-22
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 is a medical device manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2024-03-22 under approval number K231806. 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 Rezafungin Disc (5 µg) RZF5?

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K231806.

When was Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 approved by the FDA?

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 received FDA 510(k) clearance on 2024-03-22, under approval number K231806.

What company makes Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5?

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific).

What is the FDA product code for Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5?

The FDA product code for Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 is JTN.

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Related Devices (Code: JTN)

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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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