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FDA 510(k)

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

N.º K: K180073 · 2018-08-29

SolicitanteShenzhen Vitavitro Bio-Tech Co., Ltd.
Fecha de decisión2018-08-29
Código de productoMQL
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Bio-Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K180073. 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 Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Shenzhen Vitavitro Bio-Tech Co., Ltd.. The 510(k) number is K180073.

When did Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set receive FDA 510(k) clearance?

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set received FDA 510(k) clearance on 2018-08-29, under 510(k) number K180073.

Who is the listed applicant for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

The FDA 510(k) record lists Shenzhen Vitavitro Bio-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set?

The FDA product code for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set is MQL.

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Dispositivos relacionados (Código: MQL)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin 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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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