JWY
- 产品代码
- JWY
- 器械名称
- Manual Antimicrobial Susceptibility Test Systems
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.1640
- FDA 专业组
- Microbiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 24 件
- 其中 Summary 已存档
- 7 份，可直接下载
- FDA 历史累计 510(k)
- 441 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（24 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260447 | 2026-04-21 | bioMérieux SA | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | |
| K260696 | 2026-04-17 | Liofilchem s.r.l. | MTS Gepotidacin 0.016-256 µg/mL | |
| K252114 | 2025-10-02 | Liofilchem s.r.l. | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | |
| K252062 | 2025-09-25 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K250575 | 2025-09-05 | Thermo Fisher Scientific | The Sensititre 18 - 24 hour MIC or Breakpoint Suscep | — |
| K252014 | 2025-08-28 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K251580 | 2025-08-20 | Liofilchem s.r.l. | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD | |
| K250990 | 2025-06-30 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K242843 | 2025-06-20 | Thermo Fisher Scientific | The Sensititre 20-24 hour Haemophilus influenzae/Str | — |
| K250856 | 2025-06-12 | Biomérieux | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL | |
| K242659 | 2025-05-22 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K250274 | 2025-04-30 | Biomerieux S.A. | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.00 | |
| K242658 | 2025-04-15 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K243201 | 2025-02-10 | Thermo Fisher Scientific | The Sensititre 20-24 hour Haemophilus influenzae/Str | — |
| K242905 | 2025-02-10 | Thermo Fisher Scientific | The Sensititre 20-24 hour Haemophilus influenzae/Str | — |
| K243202 | 2025-01-30 | Liofilchem s.r.l. | MTS Ceftobiprole 0.002-32 µg/mL | — |
| K243169 | 2024-12-19 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K242653 | 2024-12-05 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K242657 | 2024-11-26 | Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Suscepti | — |
| K242021 | 2024-10-09 | Thermo Fisher Scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/S | — |
| K241967 | 2024-10-01 | Thermo Fisher Scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/S | — |
| K240445 | 2024-05-16 | Thermo Fisher Scientific | The Sensititre 20 - 24 hour Haemophilus influenzae/S | — |
| K232310 | 2023-10-31 | Thermo Fisher Scientific | Sensititre 20-24 hour Haemophilus influenzaelStrepto | — |
| K232395 | 2023-10-05 | Biomérieux | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/ |
FDA 官方分类页： JWY
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。