NRK

Kit, Test, Olfactory

Product code

NRK

Device name

Kit, Test, Olfactory

Device class

Class 2

21 CFR

21 CFR 874.1600

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).