Healthcheck(tm) Home Test for Loss of the Sense of Smell
DEN050007 is the FDA 510(k) clearance record for HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL, a class II device, cleared for Fmg Innovations, Inc. on under FDA product code NRK (Kit, Test, Olfactory). FDA's definition for product code NRK reads: "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...". FDA records list one 510(k) clearance for Fmg Innovations, Inc. As of , FDA records show no recalls naming DEN050007.
Clearance record
- Decision date
- Received
- (280 days to decision)
- Product code
- NRK Kit, Test, Olfactory
- Regulation
- 21 CFR 874.1600
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Applicant
- Fmg Innovations, Inc. One Financial Center, Boston MA
- Third party review
- No
Clearances, product code NRK
Trailing 12 monthsFDA records hold no clearances under product code NRK in the trailing twelve months.
Show the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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