Name: Predicase
Price: 199 USD

K-number	K042248
Device name	KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
Applicant	Kronus Market Development Associates, Inc.
Product code	NST
Device class	Class II
Decision date	Dec 17, 2004
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT

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