精子冷冻，精子冰箱
K号: K192845 · 2020-08-17
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决定日期2020-08-17
产品代码MQL
咨询委员会OB
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决定实质等同
器械摘要
Sperm Freeze, Sperm Fridge is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K192845. 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 Sperm Freeze, Sperm Fridge?
Sperm Freeze, Sperm Fridge is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Kitazato Corporation. The 510(k) number is K192845.
When did Sperm Freeze, Sperm Fridge receive FDA 510(k) clearance?
Sperm Freeze, Sperm Fridge received FDA 510(k) clearance on 2020-08-17, under 510(k) number K192845.
Who is the listed applicant for Sperm Freeze, Sperm Fridge?
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 Sperm Freeze, Sperm Fridge?
The FDA product code for Sperm Freeze, Sperm Fridge 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.K251305超快速玻璃化；超快速温控Kitazato Corporation
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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