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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 a medical device manufactured by Immuno Concepts, N.A. , Ltd.. It received FDA 510(k) clearance on 2023-05-26 under approval 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. It is manufactured by Immuno Concepts, N.A. , Ltd.. The 510(k) number is K203599.

When was Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System approved by the FDA?

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System received FDA 510(k) clearance on 2023-05-26, under approval number K203599.

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

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.

Related Clinical Trials

NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT04488224 Nano-X Image Guidance: CBCT With Gravity-induced Motion WITHDRAWN NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07042620 A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery ACTIVE_NOT_RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT05513027 Augmented Whole-body Scanning Via Magnifying PET/CT (AWSM-PET/CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the Standard-of-care (SOC) PET/CT for Malignant Lesion Detection TERMINATED

Related PubMed Literature

PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025)

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

K160265Image Navigator by Immuno Concepts K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

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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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