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FDA 510(k)

BioTeke Sterile Disposable Virus Sampling Kit

K-Number: K211707 · 2022-05-04

ApplicantBioteke Corporation (Wuxi) Co., Ltd.
Decision Date2022-05-04
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioTeke Sterile Disposable Virus Sampling Kit is a medical device manufactured by Bioteke Corporation (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-04 under approval number K211707. 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 BioTeke Sterile Disposable Virus Sampling Kit?

BioTeke Sterile Disposable Virus Sampling Kit is a medical device that received FDA 510(k) clearance on 2022-05-04. It is manufactured by Bioteke Corporation (Wuxi) Co., Ltd.. The 510(k) number is K211707.

When was BioTeke Sterile Disposable Virus Sampling Kit approved by the FDA?

BioTeke Sterile Disposable Virus Sampling Kit received FDA 510(k) clearance on 2022-05-04, under approval number K211707.

What company makes BioTeke Sterile Disposable Virus Sampling Kit?

BioTeke Sterile Disposable Virus Sampling Kit is manufactured by Bioteke Corporation (Wuxi) Co., Ltd..

What is the FDA product code for BioTeke Sterile Disposable Virus Sampling Kit?

The FDA product code for BioTeke Sterile Disposable Virus Sampling Kit is JSM.

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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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