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FDA 510(k)

BioSci™ Disposable Virus Sampling Tubes

K-Number: K230035 · 2023-04-05

ApplicantShenzhen Dakewe Bio-Engineering Co., Ltd.
Decision Date2023-04-05
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioSci™ Disposable Virus Sampling Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K230035. 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 BioSci™ Disposable Virus Sampling Tubes?

BioSci™ Disposable Virus Sampling Tubes is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K230035.

When did BioSci™ Disposable Virus Sampling Tubes receive FDA 510(k) clearance?

BioSci™ Disposable Virus Sampling Tubes received FDA 510(k) clearance on 2023-04-05, under 510(k) number K230035.

Who is the listed applicant for BioSci™ Disposable Virus Sampling Tubes?

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

What is the FDA product code for BioSci™ Disposable Virus Sampling Tubes?

The FDA product code for BioSci™ Disposable Virus Sampling Tubes is JSM.

Other records listing Shenzhen Dakewe Bio-Engineering Co., Ltd. as applicant

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.

K240235OmniTrans Transport SystemK220059Biosci™ Inactivated Transport Medium, Biosci™ ITM

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.

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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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