FDA 510(k)

Thermo Scientific Oxoid 세피디로콜 디스크 (30 µg) FDC30

K-번호: K203700 · 2021-07-30

신청자Oxoid Limited (Part of Thermo Fisher Scientific)

결정일2021-07-30

제품 코드JTN

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 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 2021-07-30 under 510(k) number K203700. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30?

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K203700.

When did Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 received FDA 510(k) clearance on 2021-07-30, under 510(k) number K203700.

Who is the listed applicant for Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30?

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 Cefiderocol Disc (30 µg) FDC30?

The FDA product code for Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 is JTN.

Oxoid Limited (Part of Thermo Fisher Scientific)를 신청인으로 등재한 기타 기록

K231806Thermo Scientific Oxoid Rezafungin 디스크 (5 µg) RZF5 K232276Thermo Scientific Oxoid Sulbactam/Durlobactam 디스크 (10/10 µg) SUD20 K203336Thermo Scientific Oxoid 오마다시클린 디스크 (30 μg) OMC30 K210873Thermo Scientific Oxoid 레파뮈린 디스크 (20µg) LMU20 K193508Thermo Scientific Oxoid 에라사이클린 디스크 (20ug) ERV20 K181975Thermo Scientific Oxoid 메르포네임/바보르바کت람 디스크 (30µg) MEV30

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