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FDA 510(k)

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

N.º K: K180202 · 2018-10-19

SolicitanteImmuno Concepts, N.A. , Ltd.
Fecha de decisión2018-10-19
Código de productoDBL
Comité asesorIM
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Immuno Concepts, N.A. , Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemK160265Image Navigator by Immuno Concepts

Fuente oficial

Ver en la base de datos de la FDA →

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