JKA
- 产品代码
- JKA
- 器械名称
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.1675
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 236 件
该代码近三年的 510(k)（25 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252899 | 2026-06-02 | Zhejiang Kindly Medical Device Co., Lt | Female Culture Device; Male Culture Device; Transfer | |
| K260128 | 2026-04-15 | Becton, Dickinson and Company | BD Preset and BD A-Line Arterial Blood Collection | FDA |
| K252506 | 2026-04-10 | Becton, Dickinson and Company | BD Vacutainer® Safety-Lok Blood Collection Set; BD | |
| K252378 | 2026-04-10 | Becton, Dickinson and Company | BD® MiniDraw Capillary Blood Collection System with | |
| K252040 | 2026-03-13 | Becton, Dickinson and Company | BD Vacutainer® Plasma Separator Tubes (PST), BD Vac | |
| K251812 | 2025-09-25 | Magnolia Medical Technologies | Steripath® Flow Blood Collection System | — |
| K243207 | 2025-07-03 | Becton, Dickinson and Company | BD Vacutainer® Eclipse Blood Collection Needle | |
| K250961 | 2025-06-04 | Promisemed Hangzhou Meditech Co., Ltd. | Blood collection tube holders | |
| K244047 | 2025-05-23 | Venocare, Inc. | Navi Needle-free Blood Collection Device (VNC20500F | |
| K250907 | 2025-04-30 | Sol-Millennium Medical, Inc. | Sol-Guard TM XtraThin Safety Pull-Button Blood Colle | |
| K243649 | 2025-03-21 | Becton, Dickinson and Company | BD Vacutainer® Multiple Sample Luer Adapter | |
| K241586 | 2025-02-27 | Becton Dickinson Infusion Therapy Syst | PIVO Pro Needle-free Blood Collection Device | FDA |
| K242320 | 2024-11-01 | Becton, Dickinson and Company | BD Vacutainer® One Use Holder | |
| K233979 | 2024-07-19 | Greiner Bio-One North America, Inc. | VACUETTE® QUICKSHIELD Complete (Plus) | |
| K232781 | 2024-03-07 | Jiangsu Caina Medical Co.,Ltd | Safety Sliding Blood Collection Set | |
| K231373 | 2024-02-02 | Becton, Dickinson and Company | BD Vacutainer® K2 EDTA Blood Collection Tubes | |
| K231282 | 2024-01-26 | Lifeoutcomes, LLC | LifeOutcomes C-Quest Blood Culture Sampling Device | |
| K231237 | 2024-01-19 | Becton, Dickinson and Company | BD Vacutainer® Fluoride Blood Collection Tubes | |
| K232881 | 2023-12-22 | Jiangsu Kangbao Medical Equipment Co., | Winged Infusion Set, Safety Winged Infusion Set, Blo | |
| K230855 | 2023-12-20 | Becton, Dickinson and Company | BD Vacutainer® Serum Separator (SST) Blood Collecti | |
| K232308 | 2023-12-04 | The Monarch Company | Monarch Blood Collection Set | |
| K230391 | 2023-12-01 | Becton, Dickinson and Company | BD MiniDraw Capillary Blood Collection System with | |
| K213146 | 2023-10-27 | Jiangsu Rongye Technology Co., Ltd. | Safety butterfly type blood collection needle, Butte | — |
| K220458 | 2023-09-29 | Innovative Medical Technologies, Inc. | UltraFlo-R Push Button Blood Collection Set | — |
| K230865 | 2023-09-28 | Becton Dickinson Infusion Therapy Syst | PIVO Pro Needle-free Blood Collection Device | FDA |
FDA 官方分类页： JKA
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。