FDA 510(k)

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

K号: K172197 · 2017-10-13

决定日期2017-10-13

产品代码MQL

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决定实质等同

器械摘要

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.

常见问题

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.

列明Origio A/S为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K200815维特里加德 K180740维特里加德 K173624ORIGIO® Handling™ 无酚红 (Cat. No. 8310), ORIGIO® Handling™ 有酚红 (Cat. No. 8311)K161547Transem和EchoGen胚胎移植导管 K162833维特里加德 K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO 精子洗涤

查看所有 8 个设备 →

相关器械（代码：MQL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254261玻璃化冷冻试剂盒和解冻试剂盒（CS-IVF-FK；CS-IVF-TK）CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248超快速升温Kitazato Corporation K252672CaseBio® Culture w/HSA (CMH5)；CaseBio® Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 生殖培养基（Dewin 精子缓冲液[含HSA和不含HSA]; Dewin 卵泡冲洗液，Dewin 一步法培养基[含HSA和不含HSA]）Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305超快速玻璃化；超快速温控Kitazato Corporation

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。