FDA 510(k)

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20

N.º K: K232276 · 2023-10-06

SolicitanteOxoid Limited (Part of Thermo Fisher Scientific)

Fecha de decisión2023-10-06

Código de productoJTN

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 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 2023-10-06 under 510(k) number K232276. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K232276.

When did Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232276.

Who is the listed applicant for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

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 Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

The FDA product code for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is JTN.

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Fuente oficial

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