Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
DEN050007Unknown

Healthcheck(tm) Home Test for Loss of the Sense of Smell

Fmg Innovations, Inc., Boston MA / Post-NSE, Unknown

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 months

FDA records hold no clearances under product code NRK in the trailing twelve months.

FDA records show no clearances under product code NRK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260