510(k) K032002

Device: FERTELL FEMALE FERTILITY TEST
Applicant: GENOSIS, INC.
510(k) number: K032002
Product code: NGA
Decision: Substantially Equivalent (SESE)
Decision date: 2003-10-30
Date received: 2003-06-27
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
K070484	QUANTRX FEMALE FERTILITY TEST	Quantrx Biomedical Corporation	2007-10-22

summary

Decision Summary