FDA 510(k) Application Details - K070484

Device Classification Name	Test, Follicle Stimulating Hormone (Fsh), Over The Counter   More FDA Info for this Device
510(K) Number	K070484
Device Name	Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Applicant	QUANTRX BIOMEDICAL CORPORATION 14033 STONEY GATE PLACE SAN DIEGO, CA 92128 US Other 510(k) Applications for this Company
Contact	LORRAINE C COGAN Other 510(k) Applications for this Contact
Regulation Number	862.1300   More FDA Info for this Regulation Number
Classification Product Code	NGA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2007
Decision Date	10/22/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review