冻存试剂盒和解冻试剂盒
K号: K171748 · 2017-12-14
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决定日期2017-12-14
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
Vitrification Kit and Thawing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K171748. 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 Vitrification Kit and Thawing Kit?
Vitrification Kit and Thawing Kit is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Kitazato Corporation. The 510(k) number is K171748.
When did Vitrification Kit and Thawing Kit receive FDA 510(k) clearance?
Vitrification Kit and Thawing Kit received FDA 510(k) clearance on 2017-12-14, under 510(k) number K171748.
Who is the listed applicant for Vitrification Kit and Thawing Kit?
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 Vitrification Kit and Thawing Kit?
The FDA product code for Vitrification Kit and Thawing Kit 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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