FDA 510(k)

ARTSMedia 实验室培养介质 (AM-IVC 介质)

K号: K220715 · 2023-02-10

决定日期2023-02-10

产品代码MQL

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决定实质等同

器械摘要

ARTSMedia In Vitro Culture Medium (AM-IVC 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 2023-02-10 under 510(k) number K220715. 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 In Vitro Culture Medium (AM-IVC Medium)?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Artsmedia Denmark Aps. The 510(k) number is K220715.

When did ARTSMedia In Vitro Culture Medium (AM-IVC Medium) receive FDA 510(k) clearance?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) received FDA 510(k) clearance on 2023-02-10, under 510(k) number K220715.

Who is the listed applicant for ARTSMedia In Vitro Culture Medium (AM-IVC 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 In Vitro Culture Medium (AM-IVC Medium)?

The FDA product code for ARTSMedia In Vitro Culture Medium (AM-IVC 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。

K241095ARTSMedia 精液洗涤介质 K241132ARTSMedia 卵母细胞吸取介质 (502020, 502050, 502100)

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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