FDA product code NRK: Kit, Test, Olfactory
NRK is the FDA product code for kit, test, olfactory. It is a Class II device, regulated under 21 CFR 874.1600 and reviewed by the Ear, Nose and Throat panel. Devices under NRK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test, Olfactory |
| Device class | Class II |
| Regulation | 21 CFR 874.1600 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for NRK devices
openFDA lists no recalls for product code NRK.
Frequently asked questions
What is FDA product code NRK?
NRK is the FDA product code for kit, test, olfactory. It is a Class II device, regulated under 21 CFR 874.1600 and reviewed by the Ear, Nose and Throat panel.
What device class is NRK?
Class II, regulation 21 CFR 874.1600. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NRK
- Run a recall and safety report across every NRK manufacturer
- Watch product code NRK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times