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510(k) K212856

iClean Viral Transport System (VTM-RT kit) by Huachenyang (Shenzhen) Technology Co. , Ltd. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2022
Date Received
September 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

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