Name: Predicase
Price: 199 USD

K-number	K101574
Device name	ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
Applicant	Ark Diagnostics, Inc.
Product code	OTF
Device class	Class II
Decision date	Nov 23, 2010
Decision	Substantially Equivalent
Regulation	862.3350

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Source

View the full FDA submission: accessdata.fda.gov

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ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

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