FDA 510(k)

Gems 老年人培养基，Gems 受精培养基，Gems 裂解培养基，Gems 胚胎培养液，Gems VitBase

K号: K161261 · 2017-05-12

决定日期2017-05-12

产品代码MQL

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决定实质等同

器械摘要

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase is the device name listed in this FDA 510(k) record. The listed applicant is Genea Biomedx Pty, Ltd.. It received FDA 510(k) clearance on 2017-05-12 under 510(k) number K161261. 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 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase?

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase is a medical device that received FDA 510(k) clearance on 2017-05-12. The listed applicant is Genea Biomedx Pty, Ltd.. The 510(k) number is K161261.

When did Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase receive FDA 510(k) clearance?

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase received FDA 510(k) clearance on 2017-05-12, under 510(k) number K161261.

Who is the listed applicant for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase?

The FDA 510(k) record lists Genea Biomedx Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase?

The FDA product code for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase is MQL.

列明Genea Biomedx 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。

K180188Geri 胚胎孵化器，配备 Geri Connect 和 Geri 评估软件，以及 Geri 碗 K180304Geri 胚胎孵化器和 Geri 碗 K171736Geri 胚胎孵化器和 Geri 碗 K170498Gems 卵母细胞采集缓冲液 ORB-20，ORB-50 K162409Gems 冻融套装，Gems 加热套装

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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