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FDA 510(k)

Disposable Sampler Inactivated Transport Media, Nest ITM

K-Number: K210440 · 2021-09-20

ApplicantWuxi Nest Biotechnology Co., Ltd.
Decision Date2021-09-20
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Disposable Sampler Inactivated Transport Media, Nest ITM is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K210440. 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 Disposable Sampler Inactivated Transport Media, Nest ITM?

Disposable Sampler Inactivated Transport Media, Nest ITM is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Wuxi Nest Biotechnology Co., Ltd.. The 510(k) number is K210440.

When did Disposable Sampler Inactivated Transport Media, Nest ITM receive FDA 510(k) clearance?

Disposable Sampler Inactivated Transport Media, Nest ITM received FDA 510(k) clearance on 2021-09-20, under 510(k) number K210440.

Who is the listed applicant for Disposable Sampler Inactivated Transport Media, Nest ITM?

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

What is the FDA product code for Disposable Sampler Inactivated Transport Media, Nest ITM?

The FDA product code for Disposable Sampler Inactivated Transport Media, Nest ITM is QBD.

Other records listing Wuxi Nest Biotechnology 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.

K240961Disposable Pen Injector AssemblyK240774Pen InjectorK211256Disposable Sampler Viral Transport Media

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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