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

Substantially Equivalent

Immuno Concepts, N.A. , Ltd.

Clearance details

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

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