QRL
- 产品代码
- QRL
- 器械名称
- Multiple Use Blood Lancet For Single Patient Use Only
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4850
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 8 件
- 其中 Summary 已存档
- 8 份,可直接下载
- FDA 历史累计 510(k)
- 27 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
该代码近三年的 510(k)(8 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K262135 | 2026-08-18 | Tianjin Huahong Technology Co., Ltd. | Lancing device | |
| K262211 | 2026-07-22 | Tianjin Huahong Technology Co., Ltd. | Lancet | |
| K260122 | 2026-07-06 | SteriLance Medical (Suzhou), Inc. | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasySt | |
| K253706 | 2025-12-09 | Tianjin Huahong Technology Co., Ltd. | Lancing device (HH-XV-T) | |
| K250813 | 2025-05-14 | Ascensia Diabetes Care U.S., Inc. | MICROLET®NEXT 2 Lancing Device | |
| K243306 | 2024-11-15 | Tianjin Huahong Technology Co., Ltd. | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, II | |
| K232912 | 2024-01-25 | Facet Technologies, LLC | Facet Aurora Reusable Lancet Base | |
| K231797 | 2023-11-22 | Medifun Corporation | Medifun Lancing Device, Model No. LD-E1 |
FDA 官方分类页: QRL
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。