FDA 510(k)

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

N.º K: K212426 · 2022-06-16

SolicitanteDonnevie Medical Technology (Shanghai) Co. , Ltd.

Fecha de decisión2022-06-16

Código de productoMQL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) is the device name listed in this FDA 510(k) record. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K212426. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])?

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K212426.

When did Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) receive FDA 510(k) clearance?

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) received FDA 510(k) clearance on 2022-06-16, under 510(k) number K212426.

Who is the listed applicant for Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])?

The FDA 510(k) record lists Donnevie Medical Technology (Shanghai) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])?

The FDA product code for Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) is MQL.

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Otros registros que enlistan a Donnevie Medical Technology (Shanghai) Co. , Ltd. como solicitante

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)K231370Dewin Blastocyst Medium (with HSA and without HSA)

Dispositivos relacionados (Código: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Fuente oficial

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