FDA 510(k)

Sydney IVF 精子缓冲液

K号: K153478 · 2016-08-15

申请人William A. Cook Australia Pty. , Ltd.

决定日期2016-08-15

产品代码MQL

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决定实质等同

器械摘要

Sydney IVF Gamete Buffer is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2016-08-15 under 510(k) number K153478. 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 Sydney IVF Gamete Buffer?

Sydney IVF Gamete Buffer is a medical device that received FDA 510(k) clearance on 2016-08-15. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K153478.

When did Sydney IVF Gamete Buffer receive FDA 510(k) clearance?

Sydney IVF Gamete Buffer received FDA 510(k) clearance on 2016-08-15, under 510(k) number K153478.

Who is the listed applicant for Sydney IVF Gamete Buffer?

The FDA 510(k) record lists William A. Cook Australia Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sydney IVF Gamete Buffer?

The FDA product code for Sydney IVF Gamete Buffer is MQL.

列明William A. Cook Australia Pty. , Ltd.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。

K173431Towako宫腔内胚胎移植套装 K171611双腔卵泡吸取针 K160753COOK 真空泵 K170257Sydney IVF 培养油 K152717Sydney IVF 胚胎冷冻保存试剂盒，Sydney IVF 胚胎解冻试剂盒 K160814Sydney IVF 精子冷冻保存缓冲液

查看所有 9 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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