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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 the device name listed in this FDA 510(k) record. The listed applicant is Huachenyang (Shenzhen) Technology Co. , Ltd.. It received FDA 510(k) clearance on 2022-08-18 under 510(k) 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. The listed applicant is Huachenyang (Shenzhen) Technology Co. , Ltd.. The 510(k) number is K212856.

When did iClean Viral Transport System (VTM-RT kit) receive FDA 510(k) clearance?

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

Who is the listed applicant for iClean Viral Transport System (VTM-RT kit)?

The FDA 510(k) record lists Huachenyang (Shenzhen) Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: JSM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242976Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceMedical Wire & Equipment Company (Bath), Ltd.K250205Babio® Virus Transport Kit (Non-inactivating)Jinan Babio Biotechnology Co., Ltd.K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia SpaK220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc.K240235OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering Co., Ltd.

Official Source

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

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