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FDA 510(k)

Biosci™ Inactivated Transport Medium, Biosci™ ITM

K-Number: K220059 · 2023-01-19

ApplicantShenzhen Dakewe Bio-Engineering Co., Ltd.
Decision Date2023-01-19
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Biosci™ Inactivated Transport Medium, Biosci™ ITM 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 2023-01-19 under 510(k) number K220059. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biosci™ Inactivated Transport Medium, Biosci™ ITM?

Biosci™ Inactivated Transport Medium, Biosci™ ITM is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K220059.

When did Biosci™ Inactivated Transport Medium, Biosci™ ITM receive FDA 510(k) clearance?

Biosci™ Inactivated Transport Medium, Biosci™ ITM received FDA 510(k) clearance on 2023-01-19, under 510(k) number K220059.

Who is the listed applicant for Biosci™ Inactivated Transport Medium, Biosci™ ITM?

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™ Inactivated Transport Medium, Biosci™ ITM?

The FDA product code for Biosci™ Inactivated Transport Medium, Biosci™ ITM is QBD.

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

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Related Devices (Code: QBD)

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.

K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLCK240797PPH Saliva Collection KitPermantis Public HealthK222771Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.K233324Molecular Transport Media - MTMAlb LuzK221547InActiv BlueFertipro NVK212878Sample preservation solutionZhejiang Gene Science 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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