510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070484Substantially Equivalent

Quantrx Female Fertility Test

Quantrx Biomedical Corporation, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070484 is the FDA 510(k) clearance record for QUANTRX FEMALE FERTILITY TEST, a class I device, cleared for Quantrx Biomedical Corporation on under FDA product code NGA (Test, Follicle Stimulating Hormone (Fsh), Over The Counter). FDA records list 4 510(k) clearances for Quantrx Biomedical Corporation, from to . As of , FDA records show no recalls naming K070484.

Clearance record

Decision date
Received
(244 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
Quantrx Biomedical Corporation 14033 Stoney Gate Pl., San Diego CA
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