SDC
- 产品代码
- SDC
- 器械名称
- Qualitative Cleaning Process Protein Indicator
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 880.6930
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract.
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| DEN230085 | 2024-11-12 | Steris | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein | — |
FDA 官方分类页: SDC
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。