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FDA 510(k)

Image Navigator by Immuno Concepts

K-Number: K160265 · 2016-06-17

ApplicantImmuno Concepts, N.A. , Ltd.
Decision Date2016-06-17
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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 2016-06-17 under 510(k) number K160265. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Image Navigator by Immuno Concepts?

Image Navigator by Immuno Concepts is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Immuno Concepts, N.A. , Ltd.. The 510(k) number is K160265.

When did Image Navigator by Immuno Concepts receive FDA 510(k) clearance?

Image Navigator by Immuno Concepts received FDA 510(k) clearance on 2016-06-17, under 510(k) number K160265.

Who is the listed applicant for 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 Image Navigator by Immuno Concepts?

The FDA product code for Image Navigator by Immuno Concepts is DHN.

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 SystemK180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

Related Devices (Code: DHN)

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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.Kg

Official Source

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

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