FDA 510(k)

Continuous Single Culture -NX (CSCM-NX)

Número K: K170681 · 2017-06-08

RequerenteIrvine Scientific Sales Co., Inc.

Data da decisão2017-06-08

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Continuous Single Culture -NX (CSCM-NX) is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K170681. 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 Continuous Single Culture -NX (CSCM-NX)?

Continuous Single Culture -NX (CSCM-NX) is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K170681.

When did Continuous Single Culture -NX (CSCM-NX) receive FDA 510(k) clearance?

Continuous Single Culture -NX (CSCM-NX) received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170681.

Who is the listed applicant for Continuous Single Culture -NX (CSCM-NX)?

The FDA 510(k) record lists Irvine Scientific Sales Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Continuous Single Culture -NX (CSCM-NX)?

The FDA product code for Continuous Single Culture -NX (CSCM-NX) is MQL.

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Outros registros que listam Irvine Scientific Sales Co., Inc. como candidato(a)

K171224Meio de Cryopreservação de Sêmen Arctic K170602Continuous Single Culture-NX Complete (CSCM-NXC)

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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