FDA 510(k) Application Details - K032002

Device Classification Name	Test, Follicle Stimulating Hormone (Fsh), Over The Counter   More FDA Info for this Device
510(K) Number	K032002
Device Name	Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Applicant	GENOSIS, INC. 1111 PENNSYLVANIA AVE,NW WASHINGTON,, DC 20004 US Other 510(k) Applications for this Company
Contact	SHARON A SEGAL 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	06/27/2003
Decision Date	10/30/2003
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