FRC
- 产品代码
- FRC
- 器械名称
- Indicator, Biological Sterilization Process
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.2800
- FDA 专业组
- General Hospital
- 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)
- 206 件
该代码近三年的 510(k)（16 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260766 | 2026-04-08 | STERIS Corporation | Celerity 5 HP Biological Indicator (LCB052) 摘要 |
| K252680 | 2025-09-24 | STERIS Corporation | Celerity 20 HP Biological Indicator 摘要 |
| K251122 | 2025-08-04 | Terragene | Terragene® Bionova® BT20 Biological Indicator 摘要 |
| K251452 | 2025-06-06 | Steris | Celerity 5 HP Biological Indicator (LCB052); Celerit 摘要 |
| K250044 | 2025-02-06 | STERIS Corporation | Celerity 5 HP Biological Indicator (LCB052); Celerit 摘要 |
| K250061 | 2025-02-06 | STERIS Corporation | Celerity Incubator 摘要 |
| K243501 | 2025-01-28 | 3M Company | 3M Attest Super Rapid Steam Extended Cycle Clear C 摘要 |
| K242453 | 2024-12-12 | Terragene S.A. | Terragene® Bionova® Photon Process Challenge Device 摘要 |
| K242538 | 2024-11-25 | 3M Company | 3M Attest Super Rapid Readout Biological Indicator 摘要 |
| K241959 | 2024-10-18 | 3M Company | 3M Attest Super Rapid Steam Clear Challenge Pack ( 摘要 |
| K231383 | 2024-09-18 | Terragene S.A. | Terragene® Bionova® Self-Contained Biological Indica |
| K241710 | 2024-09-12 | 3M Company | 3M Attest Super Rapid Readout Biological Indicator 摘要 |
| K240717 | 2024-06-27 | 3M Company | 3M Attest Rapid Readout Biological Indicator 1295 摘要 |
| K241542 | 2024-06-27 | 3M Company | 3M Attest Super Rapid Vaporized Hydrogen Peroxide 摘要 |
| K233814 | 2024-03-15 | 3M Company | 3M Attest Super Rapid Vaporized Hydrogen Peroxide 摘要 |
| K233681 | 2023-12-15 | STERIS Corporation | ConFirm 20 Minute Incubator 摘要 |
FDA 官方分类页： FRC
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。