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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 K212856
Device Name iClean Viral Transport System (VTM-RT kit)
Applicant
Huachenyang (Shenzhen) Technology Co. Ltd.
F8/Bldg 4, Hengchangrong High Industrial Park,
No.128 East Road, Shang Nan
Shenzhen,  CN 518103
Applicant Contact Robin Chu
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number866.2390
Classification Product Code
JSM  
Date Received09/08/2021
Decision Date 08/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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