QYC
- 产品代码
- QYC
- 器械名称
- Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 864.9115
- FDA 专业组
- Hematology
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
The container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.
FDA 官方分类页: QYC
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。