NRK
- 产品代码
- NRK
- 器械名称
- Kit, Test, Olfactory
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 874.1600
- FDA 专业组
- Ear, Nose, Throat
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test and an answer key, and (3) a physician information card. The device is intended for screening neurological disorder.
FDA 官方分类页： NRK
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。