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FDA 510(k)

Dewin Blastocyst Medium (with HSA and without HSA)

K-Number: K231370 · 2023-08-04

ApplicantDonnevie Medical Technology (Shanghai) Co. , Ltd.
Decision Date2023-08-04
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Dewin Blastocyst Medium (with HSA and without HSA) is a medical device manufactured by Donnevie Medical Technology (Shanghai) Co. , Ltd.. It received FDA 510(k) clearance on 2023-08-04 under approval number K231370. 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 Dewin Blastocyst Medium (with HSA and without HSA)?

Dewin Blastocyst Medium (with HSA and without HSA) is a medical device that received FDA 510(k) clearance on 2023-08-04. It is manufactured by Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K231370.

When was Dewin Blastocyst Medium (with HSA and without HSA) approved by the FDA?

Dewin Blastocyst Medium (with HSA and without HSA) received FDA 510(k) clearance on 2023-08-04, under approval number K231370.

What company makes Dewin Blastocyst Medium (with HSA and without HSA)?

Dewin Blastocyst Medium (with HSA and without HSA) is manufactured by Donnevie Medical Technology (Shanghai) Co. , Ltd..

What is the FDA product code for Dewin Blastocyst Medium (with HSA and without HSA)?

The FDA product code for Dewin Blastocyst Medium (with HSA and without HSA) is MQL.

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Other Devices by Donnevie Medical Technology (Shanghai) Co. , Ltd.

K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)

Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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