超快速玻璃化；超快速温控
K号: K251305 · 2025-08-26
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决定日期2025-08-26
产品代码MQL
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Ultra-Fast Vitri; Ultra-Fast Warm is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K251305. 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 Ultra-Fast Vitri; Ultra-Fast Warm?
Ultra-Fast Vitri; Ultra-Fast Warm is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Kitazato Corporation. The 510(k) number is K251305.
When did Ultra-Fast Vitri; Ultra-Fast Warm receive FDA 510(k) clearance?
Ultra-Fast Vitri; Ultra-Fast Warm received FDA 510(k) clearance on 2025-08-26, under 510(k) number K251305.
Who is the listed applicant for Ultra-Fast Vitri; Ultra-Fast Warm?
The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ultra-Fast Vitri; Ultra-Fast Warm?
The FDA product code for Ultra-Fast Vitri; Ultra-Fast Warm is MQL.
相关临床试验
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。
列明Kitazato Corporation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。
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 CorporationK252672CaseBio® Culture w/HSA (CMH5)；CaseBio® Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin 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.K242640FertiCult 冲洗介质；含酚红和庆大霉素的 FertiCult 冲洗介质Fertipro NV
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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