FDA 510(k)

ARTSMedia 精液洗涤介质

K号: K241095 · 2024-12-18

决定日期2024-12-18

产品代码MQL

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决定实质等同

器械摘要

ARTSMedia Semen Wash Medium is the device name listed in this FDA 510(k) record. The listed applicant is Artsmedia Denmark Aps. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K241095. 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 ARTSMedia Semen Wash Medium?

ARTSMedia Semen Wash Medium is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Artsmedia Denmark Aps. The 510(k) number is K241095.

When did ARTSMedia Semen Wash Medium receive FDA 510(k) clearance?

ARTSMedia Semen Wash Medium received FDA 510(k) clearance on 2024-12-18, under 510(k) number K241095.

Who is the listed applicant for ARTSMedia Semen Wash Medium?

The FDA 510(k) record lists Artsmedia Denmark Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTSMedia Semen Wash Medium?

The FDA product code for ARTSMedia Semen Wash Medium is MQL.

列明Artsmedia Denmark Aps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。

K241132ARTSMedia 卵母细胞吸取介质 (502020, 502050, 502100)K220715ARTSMedia 实验室培养介质 (AM-IVC 介质)

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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