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FDA 510(k)

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

Número K: K180202 · 2018-10-19

RequerenteImmuno Concepts, N.A. , Ltd.
Data da decisão2018-10-19
Código do produtoDBL
Comité consultivoIM
DecisãoSubstantially Equivalent

Resumo do dispositivo

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts 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 2018-10-19 under 510(k) number K180202. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts?

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Immuno Concepts, N.A. , Ltd.. The 510(k) number is K180202.

When did Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts receive FDA 510(k) clearance?

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts received FDA 510(k) clearance on 2018-10-19, under 510(k) number K180202.

Who is the listed applicant for Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts?

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 Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts?

The FDA product code for Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts is DBL.

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Fonte oficial

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