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FDA 510(k)

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

K-Number: K200408 · 2020-10-16

Decision Date2020-10-16
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium is a medical device manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-10-16 under approval number K200408. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium is a medical device that received FDA 510(k) clearance on 2020-10-16. It is manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K200408.

When was VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium approved by the FDA?

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium received FDA 510(k) clearance on 2020-10-16, under approval number K200408.

What company makes VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium is manufactured by Shenzhen Vitavitro Biotech Co., Ltd..

What is the FDA product code for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

The FDA product code for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium is MQL.

Related Clinical Trials

Other Devices by Shenzhen Vitavitro Biotech Co., Ltd.

Related Devices (Code: MQL)

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.