Product code NRK

Device name
Kit, Test, Olfactory
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation number
874.1600
Review panel
EN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset