FDA 510(k)

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

Número K: K181975 · 2018-09-27

RequerenteOxoid Limited (Part of Thermo Fisher Scientific)

Data da decisão2018-09-27

Código do produtoJTN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 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 2018-09-27 under 510(k) number K181975. 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 Meropenem/Vaborbactam Disc (30µg) MEV30?

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is a medical device that received FDA 510(k) clearance on 2018-09-27. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K181975.

When did Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 received FDA 510(k) clearance on 2018-09-27, under 510(k) number K181975.

Who is the listed applicant for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30?

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 Meropenem/Vaborbactam Disc (30µg) MEV30?

The FDA product code for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is JTN.

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