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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 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.

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. 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.

Other records listing Immuno Concepts, N.A. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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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