510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032002Substantially Equivalent

Fertell Female Fertility Test

Genosis, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032002 is the FDA 510(k) clearance record for FERTELL FEMALE FERTILITY TEST, a class I device, cleared for Genosis, Inc. on under FDA product code NGA (Test, Follicle Stimulating Hormone (Fsh), Over The Counter). FDA records list 2 510(k) clearances for Genosis, Inc., from to . As of , FDA records show no recalls naming K032002.

Clearance record

Decision date
Received
(125 days to decision)
Product code
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Regulation
21 CFR 862.1300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Genosis, Inc. 1111 Pennsylvania Ave., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NGA

Trailing 12 months

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

FDA records show no clearances under product code NGA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NGA, 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