FDA 510(k)

SepaSperm Washing Solution, SepaSperm Solution

Número K: K190199 · 2019-09-26

Data da decisão2019-09-26

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

SepaSperm Washing Solution, SepaSperm Solution is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K190199. 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 SepaSperm Washing Solution, SepaSperm Solution?

SepaSperm Washing Solution, SepaSperm Solution is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Kitazato Corporation. The 510(k) number is K190199.

When did SepaSperm Washing Solution, SepaSperm Solution receive FDA 510(k) clearance?

SepaSperm Washing Solution, SepaSperm Solution received FDA 510(k) clearance on 2019-09-26, under 510(k) number K190199.

Who is the listed applicant for SepaSperm Washing Solution, SepaSperm Solution?

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

What is the FDA product code for SepaSperm Washing Solution, SepaSperm Solution?

The FDA product code for SepaSperm Washing Solution, SepaSperm Solution is MQL.

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Outros registros que listam Kitazato Corporation como candidato(a)

K260248Ultra-Fast Warm K251305Ultra-Fast Vitri; Ultra-Fast Warm K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA K192845Sperm Freeze, Sperm Fridge K192540Kitazato ET Catheters

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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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