iClean Viral Transport System (VTM-RT kit)— 510(k) K212856

Name: FDA 510(k) clearance K212856
Creator: U.S. Food and Drug Administration
Published: 2022-08-18

Substantially Equivalent

Huachenyang (Shenzhen) Technology Co. , Ltd.

FDA 510(k) clearance K212856 for iClean Viral Transport System (VTM-RT kit), Substantially Equivalent on 2022-08-18. Applicant: Huachenyang (Shenzhen) Technology Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Huachenyang (Shenzhen) Technology Co. , Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2021-09-08
Decision date: 2022-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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