DeviceClearance

Product code NRK— Ear, Nose, Throat

HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL

Classification name
Kit, Test, Olfactory
Device class
Class 2
Regulation
21 CFR 874.1600
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NRK under 21 CFR 874.1600, via openFDA

Market context for product code NRK

FDA has cleared 1 device under product code NRK, all in 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NRK

Recent clearances under product code NRK

Data sourced from openFDA. This site is unofficial and independent of the FDA.