K-number	K192665
Device name	Accelerate Pheno System, Accelerate PhenoTest BC Kit
Applicant	Accelerate Diagnostics, Inc.
Product code	PRH
Device class	Class II
Decision date	Sep 15, 2020
Decision	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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