Cleared Traditional

ARX Liquid Amies Collection & Transport System

K222613 · Arx Sciences, Inc. · Microbiology
Mar 2024
Decision
575d
Days
Class 1
Risk

About This 510(k) Submission

K222613 is an FDA 510(k) clearance for the ARX Liquid Amies Collection & Transport System, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Arx Sciences, Inc. (Amherst, US). The FDA issued a Cleared decision on March 27, 2024, 575 days after receiving the submission on August 30, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K222613 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2022
Decision Date March 27, 2024
Days to Decision 575 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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