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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K222613
Device Name ARX Liquid Amies Collection & Transport System
Applicant
Arx Sciences, Inc.
160 Lawrence Bell Dr.
Suite 120
Amherst,  NY  14221
Applicant Contact Chad Werts
Correspondent
Arx Sciences, Inc.
160 Lawrence Bell Dr.
Suite 120
Amherst,  NY  14221
Correspondent Contact Chad Werts
Regulation Number866.2900
Classification Product Code
LIO  
Subsequent Product Codes
JTW   JTX  
Date Received08/30/2022
Decision Date 03/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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