FDA 510(k)

Accelerate Arc System

K-Number: K240854 · 2024-09-26

Decision Date2024-09-26

Product CodeQNJ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Accelerate Arc System is the device name listed in this FDA 510(k) record. The listed applicant is Accelerate Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) 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. The listed applicant is Accelerate Diagnostics, Inc.. The 510(k) number is K240854.

When did Accelerate Arc System receive FDA 510(k) clearance?

Accelerate Arc System received FDA 510(k) clearance on 2024-09-26, under 510(k) number K240854.

Who is the listed applicant for Accelerate Arc System?

The FDA 510(k) record lists Accelerate Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accelerate Arc System?

The FDA product code for Accelerate Arc System is QNJ.

Other records listing Accelerate Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192665Accelerate Pheno System, Accelerate PhenoTest BC Kit

Related Devices (Code: QNJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.