MiniCollect K2E K2EDTA管
K号: K182078 · 2019-01-25
广告
决定日期2019-01-25
产品代码JKA
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
MiniCollect K2E K2EDTA Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K182078. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MiniCollect K2E K2EDTA Tubes?
MiniCollect K2E K2EDTA Tubes is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K182078.
When did MiniCollect K2E K2EDTA Tubes receive FDA 510(k) clearance?
MiniCollect K2E K2EDTA Tubes received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182078.
Who is the listed applicant for MiniCollect K2E K2EDTA Tubes?
The FDA 510(k) record lists Greiner Bio-One Na, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MiniCollect K2E K2EDTA Tubes?
The FDA product code for MiniCollect K2E K2EDTA Tubes is JKA.
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Greiner Bio-One Na, Inc.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：JKA）
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。
K262215Profoject™ 安全滑动采血套装CMT Health PTE., Ltd.K252899女性培养装置；男性培养装置；转移装置；接入装置Zhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ 和 BD A-Line™ 动脉血采集注射器Becton, Dickinson and CompanyK252378BD® MiniDraw™ 细胞毛细管血样采集系统带 BD® MiniDraw™ SST™ 细胞毛细管血样采集管Becton, Dickinson and CompanyK252506BD Vacutainer® 安全锁定® 血样采集套装; BD Vacutainer® 安全锁定® 血样采集套装带预装夹具Becton, Dickinson and CompanyK252040BD Vacutainer® 血浆分离管 (PST™), BD Vacutainer® 乙二胺四乙酸二钠血样采集管Becton, Dickinson and Company
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