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FDA 510(k)

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

K-Number: K203599 · 2023-05-26

ApplicantImmuno Concepts, N.A. , Ltd.
Decision Date2023-05-26
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsK160265Image Navigator by Immuno Concepts

Related Devices (Code: KTL)

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.

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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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