510(k) K070484

Device: QUANTRX FEMALE FERTILITY TEST
Applicant: QUANTRX BIOMEDICAL CORPORATION
510(k) number: K070484
Product code: NGA
Decision: Substantially Equivalent (SESE)
Decision date: 2007-10-22
Date received: 2007-02-20
Regulation: 862.1300
Classification name: Test, Follicle Stimulating Hormone (fsh), Over The Counter
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K032002	FERTELL FEMALE FERTILITY TEST	Genosis, Inc.	2003-10-30

summary

Decision Summary