FDA 510(k)

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5

Número K: K231806 · 2024-03-22

RequerenteOxoid Limited (Part of Thermo Fisher Scientific)

Data da decisão2024-03-22

Código do produtoJTN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K231806. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K231806.

When did Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 receive FDA 510(k) clearance?

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

Who is the listed applicant for Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5?

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

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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