# Kit, Test, Olfactory
> **Product code: NRK** · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.1600
## Classification
- **FDA Product Code:** NRK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 874.1600
- **Review panel:** EN
- **Medical specialty:** Ear, Nose, Throat
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NRK)
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