NRK

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Kit, Test, Olfactory

Device class

Class II (moderate risk)

Regulation

21 CFR 874.1600

Medical specialty

Ear, Nose, Throat

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.

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.