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FDA 510(k)

iClean Viral Transport System (VTM-RT kit)

K-Number: K212856 · 2022-08-18

ApplicantHuachenyang (Shenzhen) Technology Co. , Ltd.
Decision Date2022-08-18
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

iClean Viral Transport System (VTM-RT kit) is a medical device manufactured by Huachenyang (Shenzhen) Technology Co. , Ltd.. It received FDA 510(k) clearance on 2022-08-18 under approval number K212856. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iClean Viral Transport System (VTM-RT kit)?

iClean Viral Transport System (VTM-RT kit) is a medical device that received FDA 510(k) clearance on 2022-08-18. It is manufactured by Huachenyang (Shenzhen) Technology Co. , Ltd.. The 510(k) number is K212856.

When was iClean Viral Transport System (VTM-RT kit) approved by the FDA?

iClean Viral Transport System (VTM-RT kit) received FDA 510(k) clearance on 2022-08-18, under approval number K212856.

What company makes iClean Viral Transport System (VTM-RT kit)?

iClean Viral Transport System (VTM-RT kit) is manufactured by Huachenyang (Shenzhen) Technology Co. , Ltd..

What is the FDA product code for iClean Viral Transport System (VTM-RT kit)?

The FDA product code for iClean Viral Transport System (VTM-RT kit) is JSM.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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