FDA 510(k)

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

Número K: K203336 · 2022-09-15

RequerenteOxoid Limited (Part of Thermo Fisher Scientific)

Data da decisão2022-09-15

Código do produtoJTN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 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 2022-09-15 under 510(k) number K203336. 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 Omadacycline Disc (30 ug) OMC30?

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K203336.

When did Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 received FDA 510(k) clearance on 2022-09-15, under 510(k) number K203336.

Who is the listed applicant for Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30?

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 Omadacycline Disc (30 ug) OMC30?

The FDA product code for Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 is JTN.

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Outros registros que listam Oxoid Limited (Part of Thermo Fisher Scientific) como candidato(a)

K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 K232276Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 K210873Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 K203700Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 K193508Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

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Fonte oficial

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