Accelerate Arc System
K-Number: K240854 · 2024-09-26
ApplicantAccelerate Diagnostics, Inc.
Decision Date2024-09-26
Product CodeQNJ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Accelerate Arc System is a medical device manufactured by Accelerate Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-09-26 under approval number K240854. The device is classified under product code QNJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Accelerate Arc System?
Accelerate Arc System is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Accelerate Diagnostics, Inc.. The 510(k) number is K240854.
When was Accelerate Arc System approved by the FDA?
Accelerate Arc System received FDA 510(k) clearance on 2024-09-26, under approval number K240854.
What company makes Accelerate Arc System?
Accelerate Arc System is manufactured by Accelerate Diagnostics, Inc..
What is the FDA product code for Accelerate Arc System?
The FDA product code for Accelerate Arc System is QNJ.
Related Clinical Trials
Other Devices by Accelerate Diagnostics, Inc.
Related Devices (Code: QNJ)
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.