NRK — Kit, Test, Olfactory Class II
FDA product code NRK covers "Kit, Test, Olfactory", a Class II medical device regulated under 21 CFR 874.1600. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NRK
- Device Class
- Class II
- Regulation Number
- 874.1600
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN050007 | fmg innovations | HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL | March 27, 2006 |