FDA 510(k)

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

Номер K: K172197 · 2017-10-13

ЗаявительOrigio A/S

Дата решения2017-10-13

Код продуктаMQL

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS is the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K172197. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Origio A/S. The 510(k) number is K172197.

When did SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS receive FDA 510(k) clearance?

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS received FDA 510(k) clearance on 2017-10-13, under 510(k) number K172197.

Who is the listed applicant for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

The FDA 510(k) record lists Origio A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

The FDA product code for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS is MQL.

Другие записи, где Origio A/S указан как заявитель

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

K200815VitriGuard K180740VitriGuard K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)K161547Transem and EchoGen Embryo Transfer Catheters K162833VitriGuard K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

Посмотреть все 8 устройств →

Связанные устройства (Код: 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

Официальный источник

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