FDA 510(k)

AESKUSLIDES ANCA 에탄올, AESKUSLIDES ANCA 포말린

K-번호: K172461 · 2018-03-23

결정일2018-03-23

제품 코드MOB

자문 위원회IM

결정Substantially Equivalent

기기 요약

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin is the device name listed in this FDA 510(k) record. The listed applicant is Aesku.Diagnostics GmbH & Co. KG. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K172461. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin?

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Aesku.Diagnostics GmbH & Co. KG. The 510(k) number is K172461.

When did AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin receive FDA 510(k) clearance?

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin received FDA 510(k) clearance on 2018-03-23, under 510(k) number K172461.

Who is the listed applicant for AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin?

The FDA 510(k) record lists Aesku.Diagnostics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin?

The FDA product code for AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin is MOB.

Aesku.Diagnostics GmbH & Co. KG를 신청인으로 등재한 기타 기록

K172348AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) 데모 키트, AESKUSLIDES nDNA (Crithidia luciliae) 백키트 x5, AESKUSLIDES nDNA (Crithidia luciliae) 백키트 x10

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