FDA 510(k)

OncoMate MSI Dx Analysis System

K-번호: K200129 · 2021-07-26

결정일2021-07-26

제품 코드PZJ

자문 위원회IM

결정Substantially Equivalent

기기 요약

OncoMate MSI Dx Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Promega Corporation. It received FDA 510(k) clearance on 2021-07-26 under 510(k) number K200129. The device is classified under product code PZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the OncoMate MSI Dx Analysis System?

OncoMate MSI Dx Analysis System is a medical device that received FDA 510(k) clearance on 2021-07-26. The listed applicant is Promega Corporation. The 510(k) number is K200129.

When did OncoMate MSI Dx Analysis System receive FDA 510(k) clearance?

OncoMate MSI Dx Analysis System received FDA 510(k) clearance on 2021-07-26, under 510(k) number K200129.

Who is the listed applicant for OncoMate MSI Dx Analysis System?

The FDA 510(k) record lists Promega Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OncoMate MSI Dx Analysis System?

The FDA product code for OncoMate MSI Dx Analysis System is PZJ.

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OncoMate MSI Dx Analysis System

기기 요약

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관련 임상시험

관련 기기 (코드: PZJ)

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