Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System— 510(k) K203599

Name: FDA 510(k) clearance K203599
Creator: U.S. Food and Drug Administration
Published: 2023-05-26

Substantially Equivalent

Immuno Concepts, N.A. , Ltd.

FDA 510(k) clearance K203599 for Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System, Substantially Equivalent on 2023-05-26. Applicant: Immuno Concepts, N.A. , Ltd.. Device class: 2.

Clearance details

Applicant: Immuno Concepts, N.A. , Ltd.
Product code: Code KTL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2020-12-09
Decision date: 2023-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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