K-number	K101305
Device name	ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
Applicant	Ark Diagnostics, Inc.
Product code	ORH
Device class	Class II
Decision date	Oct 29, 2010
Decision	Substantially Equivalent
Regulation	862.3350

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View the full FDA submission: accessdata.fda.gov

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ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

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