Accelerate Pheno System, Accelerate PhenoTest BC Kit
K-Number: K192665 · 2020-09-15
ApplicantAccelerate Diagnostics, Inc.
Decision Date2020-09-15
Product CodePRH
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Accelerate Pheno System, Accelerate PhenoTest BC Kit is a medical device manufactured by Accelerate Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-09-15 under approval number K192665. The device is classified under product code PRH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Accelerate Pheno System, Accelerate PhenoTest BC Kit?
Accelerate Pheno System, Accelerate PhenoTest BC Kit is a medical device that received FDA 510(k) clearance on 2020-09-15. It is manufactured by Accelerate Diagnostics, Inc.. The 510(k) number is K192665.
When was Accelerate Pheno System, Accelerate PhenoTest BC Kit approved by the FDA?
Accelerate Pheno System, Accelerate PhenoTest BC Kit received FDA 510(k) clearance on 2020-09-15, under approval number K192665.
What company makes Accelerate Pheno System, Accelerate PhenoTest BC Kit?
Accelerate Pheno System, Accelerate PhenoTest BC Kit is manufactured by Accelerate Diagnostics, Inc..
What is the FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit?
The FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit is PRH.
Related Clinical Trials
Other Devices by Accelerate Diagnostics, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.