Cleared Traditional

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

K203599 · Immuno Concepts, N.A. , Ltd. · Immunology
May 2023
Decision
898d
Days
Class 2
Risk

About This 510(k) Submission

K203599 is an FDA 510(k) clearance for the Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System, a Anti-dna Indirect Immunofluorescent Solid Phase (Class II — Special Controls, product code KTL), submitted by Immuno Concepts, N.A. , Ltd. (Sacramento, US). The FDA issued a Cleared decision on May 26, 2023, 898 days after receiving the submission on December 9, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K203599 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2020
Decision Date May 26, 2023
Days to Decision 898 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code KTL — Anti-dna Indirect Immunofluorescent Solid Phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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