K-number	K220085
Device name	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Applicant	Kronus, Inc.
Product code	OIF
Device class	Class II
Decision date	Aug 24, 2023
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

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