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FDA 510(k)

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

K-Number: K180202 · 2018-10-19

ApplicantImmuno Concepts, N.A. , Ltd.
Decision Date2018-10-19
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Immuno Concepts, N.A. , Ltd.. The 510(k) number is K180202.

When was Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts approved by the FDA?

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

What company makes 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 manufactured by Immuno Concepts, N.A. , Ltd..

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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Related PubMed Literature

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Other Devices by Immuno Concepts, N.A. , Ltd.

K160265Image Navigator by Immuno Concepts K203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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