JOJ
- 产品代码
- JOJ
- 器械名称
- Indicator, Physical/Chemical 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)
- 264 件
该代码近三年的 510(k)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260181 | 2026-02-20 | Intertape Polymer Group | LF Process Indicator Tape for Steam Sterilization | FDA |
| K251991 | 2025-12-23 | Shenzhen Safesecure Medical Infection | SafeSecure Steam Sterilization Process Indicator (40 | |
| K251035 | 2025-06-03 | Serim Research | DISINTEK PA Test Strips | |
| K251048 | 2025-05-02 | STERIS Corporation | Rapicide PA High-Level Disinfection Test Strip Mode | |
| K243876 | 2025-04-25 | STERIS Corporation | VERIFY STEAM Integrating Indicator | |
| K250172 | 2025-02-20 | Steritec Products, Inc. (A Getinge Com | Green Card Bowie-Dick Test (BD115) | |
| K242860 | 2025-01-17 | True Indicating, LLC | Type 5 Integrating Indicator for Steam (CSPN-15) | FDA |
| K241036 | 2024-12-17 | Jiangmen New Era External Use Drug Co. | Autoclave Indicator Tape; EO Indicator Tape | |
| K243475 | 2024-12-04 | STERIS Corporation | Chemical Indicator for enspire CLCSPS (LCC015) | |
| K242795 | 2024-10-15 | Steritec Products Mfg. (A Getinge Grou | Getinge Assured MI Steam Migrating Integrator | |
| K241836 | 2024-09-30 | Kem Medical Products Corporation | Kem Medical Lead-free Chemical Indicators for Steam | |
| K242189 | 2024-08-20 | Steris | CELERITY HP Indicator Tape (PCC077) | |
| K234084 | 2024-07-05 | Advanced Sterilization Products, Inc. | STERRAD Chemical Indicator (CI) Strip (14100); STER | FDA |
| K233413 | 2024-06-26 | True Indicating, LLC | Ultraphon Chemical Indicator (TRO-T and TRO-B) | |
| K240910 | 2024-06-12 | Propper Manufacturing Co., Inc. | EO Chex Indicator Tape | |
| K241344 | 2024-06-11 | Steris | MetriCide OPA Plus Solution Test Strip | |
| K240032 | 2024-04-17 | STERIS Corporation | Celerity Chemical Indicator for enspire 3000 CLCSPS | FDA |
| K240760 | 2024-04-10 | Steris | CELERITY HP Indicator Tape | |
| K233654 | 2023-12-08 | Steris | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM | |
| K233187 | 2023-10-27 | Steris | Celerity Vaporized VH2O2 Process Indicator Adhesive |
FDA 官方分类页： JOJ
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。