NRKClass II
Kit, Test, Olfactory
21 CFR 874.1600 / Ear, Nose, Throat
NRK is the FDA product code for Kit, Test, Olfactory, a class II device type, regulated under 21 CFR 874.1600. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NRK
- Device name
- Kit, Test, Olfactory
- FDA 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.
- Regulation
- 21 CFR 874.1600
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code NRK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
Applicants with the most clearances
Product code NRK| Applicant | Clearances |
|---|---|
| Fmg Innovations, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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