K-number	DEN160003
Device name	Quantidex qPCR BCR-ABL IS Kit
Applicant	Asuragen, Inc.
Product code	OYX
Device class	Class II
Decision date	Jul 22, 2016
Decision	Not Substantially Equivalent
Regulation	866.6060

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View the full FDA submission: accessdata.fda.gov

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Quantidex qPCR BCR-ABL IS Kit

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