K-number	K181661
Device name	QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Applicant	Bio-Rad Laboratories, Inc.
Product code	OYX
Device class	Class II
Decision date	Feb 13, 2019
Decision	Substantially Equivalent
Regulation	866.6060

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Source

View the full FDA submission: accessdata.fda.gov

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QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

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