Abbott Laboratories
FDA 510(k) & PMA Approved 器械 — 28 products
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器械总数28
类别0
最新FDA决定
| 类型 | 编号 | 器械名称 | 代码 | 日期 | 操作 |
|---|---|---|---|---|---|
| 510(k) | K262156 | 抗HCV Next | MZO | 2026-09-23 | 查看 |
| 510(k) | K252424 | 抗HCV Next | MZO | 2026-04-28 | 查看 |
| 510(k) | K243500 | ARCHITECT 链霉素 | LCD | 2025-07-09 | 查看 |
| 510(k) | K243168 | Alinity i 风疹IgG | LFX | 2025-06-20 | 查看 |
| 510(k) | K243283 | Alinity h系列系统 | GKZ | 2025-02-20 | 查看 |
| 510(k) | K233932 | Alinity i Toxo IgM | LGD | 2024-08-30 | 查看 |
| 510(k) | K232669 | TBI | QAT | 2023-09-29 | 查看 |
| 510(k) | K222850 | HAVAb IgG II | LOL | 2023-08-10 | 查看 |
| 510(k) | K220031 | Alinity h系列系统 | GKZ | 2023-08-04 | 查看 |
| 510(k) | K220282 | i-STAT PTplus 芯片与 i-STAT 1 系统 | GJS | 2023-07-14 | 查看 |
| 510(k) | K230937 | Alinity i 总β-hCG试剂套件，GLP系统追踪 | DHA | 2023-06-05 | 查看 |
| 510(k) | K230790 | Alinity i 总β-hCG试剂套件，Alinity c 葡萄糖试剂套件，Alinity c ICT样本稀释液，Alinity ci系列 | DHA | 2023-05-19 | 查看 |
| 510(k) | K223602 | 脑外伤（TBI）测试 | QAT | 2023-03-02 | 查看 |
| 510(k) | K220949 | Architect CMV IgG | LFZ | 2022-10-27 | 查看 |
| 510(k) | K210596 | ARCHITECT 弓形虫IgG | LGD | 2022-05-19 | 查看 |
| 510(k) | K213486 | GLP 系统跟踪 | JGS | 2022-03-10 | 查看 |
| 510(k) | K201778 | i-STAT TBI 血浆模块，适用于 i-STAT Alinity 系统 | QAT | 2021-01-08 | 查看 |
| 510(k) | K190294 | CELL-DYN Emerald 22 AL系统 | GKZ | 2019-03-15 | 查看 |
| 510(k) | K181748 | Magnesium | JGJ | 2018-09-12 | 查看 |
| 510(k) | K173294 | Magnesium | JGJ | 2018-05-18 | 查看 |
没有匹配的设备。