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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 the device name listed in this FDA 510(k) record. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) 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. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. The 510(k) number is K211707.

When did BioTeke Sterile Disposable Virus Sampling Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for BioTeke Sterile Disposable Virus Sampling Kit?

The FDA 510(k) record lists Bioteke Corporation (Wuxi) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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.

NCT03598946Urinary Human Papilloma Virus Test in the General Population in BrittanyTERMINATED

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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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