FDA 510(k)

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

Número K: K210873 · 2021-10-27

RequerenteOxoid Limited (Part of Thermo Fisher Scientific)

Data da decisão2021-10-27

Código do produtoJTN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 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 2021-10-27 under 510(k) number K210873. 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 Lefamulin Disc (20µg) LMU20?

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 is a medical device that received FDA 510(k) clearance on 2021-10-27. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K210873.

When did Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 received FDA 510(k) clearance on 2021-10-27, under 510(k) number K210873.

Who is the listed applicant for Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20?

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 Lefamulin Disc (20µg) LMU20?

The FDA product code for Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 is JTN.

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