FDA 510(k)

Dewin 胚胎培养液（含HSA和不含HSA）

K号: K231370 · 2023-08-04

申请人Donnevie Medical Technology (Shanghai) Co. , Ltd.

决定日期2023-08-04

产品代码MQL

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决定实质等同

器械摘要

Dewin Blastocyst Medium (with HSA and without HSA) is the device name listed in this FDA 510(k) record. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K231370. 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 Dewin Blastocyst Medium (with HSA and without HSA)?

Dewin Blastocyst Medium (with HSA and without HSA) is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Donnevie Medical Technology (Shanghai) Co. , Ltd.. The 510(k) number is K231370.

When did Dewin Blastocyst Medium (with HSA and without HSA) receive FDA 510(k) clearance?

Dewin Blastocyst Medium (with HSA and without HSA) received FDA 510(k) clearance on 2023-08-04, under 510(k) number K231370.

Who is the listed applicant for Dewin Blastocyst Medium (with HSA and without HSA)?

The FDA 510(k) record lists Donnevie Medical Technology (Shanghai) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dewin Blastocyst Medium (with HSA and without HSA)?

The FDA product code for Dewin Blastocyst Medium (with HSA and without HSA) is MQL.

列明Donnevie Medical Technology (Shanghai) Co. , 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。

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]）K242561Dewin 生殖培养基（Dewin 降温试剂盒，Dewin 解冻试剂盒）K212426Dewin 生殖培养基（Dewin 受精培养基[含HSA和不含HSA]和Dewin 裂解培养基[含HSA和不含HSA]）

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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