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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name culture media, non-propagating transport
510(k) Number K231843
Device Name ARX Viral Transport Media Collection and Transport System
Applicant
ARX Sciences, Inc.
160 Lawrence Bell Drive
Suite 120
Amherst,  NY  14221
Applicant Contact Chad Werts
Correspondent
ARX Sciences, Inc.
160 Lawrence Bell Drive
Suite 120
Amherst,  NY  14221
Correspondent Contact Chad Werts
Regulation Number866.2390
Classification Product Code
JSM  
Date Received06/22/2023
Decision Date 03/19/2024
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
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