Name: Predicase
Price: 199 USD

K-number	K203599
Device name	Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Applicant	Immuno Concepts, N.A. , Ltd.
Product code	KTL
Device class	Class II
Decision date	May 26, 2023
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.