K-number	DEN160032
Device name	Accelerate Pheno system, Accelerate Phenotest BC Kit
Applicant	Accelerate Diagnotics
Product code	PRH
Device class	Class II
Decision date	Feb 23, 2017
Decision	Not Substantially Equivalent
Regulation	866.1650

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Source

View the full FDA submission: accessdata.fda.gov

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Accelerate Pheno system, Accelerate Phenotest BC Kit

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