Name: Predicase
Price: 199 USD

K-number	K180202
Device name	Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
Applicant	Immuno Concepts, N.A. , Ltd.
Product code	DBL
Device class	Class II
Decision date	Oct 19, 2018
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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

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