Accelerate Arc System— 510(k) K240854

Name: FDA 510(k) clearance K240854
Creator: U.S. Food and Drug Administration
Published: 2024-09-26

Substantially Equivalent

Accelerate Diagnostics, Inc.

FDA 510(k) clearance K240854 for Accelerate Arc System, Substantially Equivalent on 2024-09-26. Applicant: Accelerate Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Accelerate Diagnostics, Inc.
Product code: Code QNJ
Device class: Class 2
Regulation: 21 CFR 866.3378
Advisory panel: Microbiology
Date received: 2024-03-28
Decision date: 2024-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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