Name: Predicase
Price: 199 USD

K-number	K153596
Device name	ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
Applicant	Ark Diagnostics, Inc.
Product code	POX
Device class	Class II
Decision date	Aug 9, 2016
Decision	Substantially Equivalent
Regulation	862.3645

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Source

View the full FDA submission: accessdata.fda.gov

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ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

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