FDA 510(k)

Vitrification Solution Set and Warming Solution Set

Número K: K233846 · 2024-08-27

Data da decisão2024-08-27

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vitrification Solution Set and Warming Solution Set is the device name listed in this FDA 510(k) record. The listed applicant is Ecmpc, LLC. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K233846. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vitrification Solution Set and Warming Solution Set?

Vitrification Solution Set and Warming Solution Set is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Ecmpc, LLC. The 510(k) number is K233846.

When did Vitrification Solution Set and Warming Solution Set receive FDA 510(k) clearance?

Vitrification Solution Set and Warming Solution Set received FDA 510(k) clearance on 2024-08-27, under 510(k) number K233846.

Who is the listed applicant for Vitrification Solution Set and Warming Solution Set?

The FDA 510(k) record lists Ecmpc, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitrification Solution Set and Warming Solution Set?

The FDA product code for Vitrification Solution Set and Warming Solution Set is MQL.

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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

Fonte oficial

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