Kit, Test, Olfactory
The Olfactory Test Kit is a home-use device for screening loss of the sense of smell, which may indicate underlying neurological disorders. The kit contains an instruction book, a booklet with twelve microencapsulated smell strips on separate pages with scoring instructions and an answer key, and a physician information card. It is an FDA Class 2 device regulated under 21 CFR 874.1600 in the Ear, Nose, and Throat specialty, with product code NRK, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support flags.
Basic Information
- Product Code
- NRK
- Device Class
- FDA class 2
- Regulation Number
- 874.1600
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN050007 | HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL | Mar 27, 2006 | Unknown | FMG INNOVATIONS, INC. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.