510(k) DEN050007
DEN050007 is an FDA 510(k) premarket notification submitted by Fmg Innovations, Inc. for the device "HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL". The FDA issued a decision of De Novo Granted on March 27, 2006. The device falls under product code NRK (Kit, Test, Olfactory), a Class II device regulated under 21 CFR 874.1600.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 27, 2006
- Date Received
- June 20, 2005
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Test, Olfactory
- Device Class
- Class II
- Regulation Number
- 874.1600
- Review Panel
- EN
- Submission Type
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.