FDA 510(k)

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA荧光 검사 시스템

K-번호: K203599 · 2023-05-26

결정일2023-05-26

제품 코드KTL

자문 위원회IM

결정대체적으로 동일

기기 요약

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, N.A. , Ltd.. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K203599. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System?

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Immuno Concepts, N.A. , Ltd.. The 510(k) number is K203599.

When did Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System receive FDA 510(k) clearance?

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System received FDA 510(k) clearance on 2023-05-26, under 510(k) number K203599.

Who is the listed applicant for Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System?

The FDA 510(k) record lists Immuno Concepts, N.A. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System?

The FDA product code for Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System is KTL.

Immuno Concepts, N.A. , Ltd.를 신청인으로 등재한 기타 기록

K180202히스토플루오어 라ット LKS 플루오레스센스 항체 검사 시스템, 이미지 네비게이터 by 이무노 콘셉트 K160265이미지 네비게이터 by Immuno Concepts

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