1步培养介质
K号: K191063 · 2019-08-23
广告
决定日期2019-08-23
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
1-Step Culture Medium is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K191063. 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 1-Step Culture Medium?
1-Step Culture Medium is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K191063.
When did 1-Step Culture Medium receive FDA 510(k) clearance?
1-Step Culture Medium received FDA 510(k) clearance on 2019-08-23, under 510(k) number K191063.
Who is the listed applicant for 1-Step Culture Medium?
The FDA 510(k) record lists Shenzhen Vitavitro Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 1-Step Culture Medium?
The FDA product code for 1-Step Culture Medium 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Shenzhen Vitavitro Biotech 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。
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。
广告