FDA 510(k) Application Details - K002450

Device Classification Name	Radioimmunoassay, Follicle-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K002450
Device Name	Radioimmunoassay, Follicle-Stimulating Hormone
Applicant	GENUA 1944, INC. 53 CEDAR LAKE RD. BLAIRSTOWN, NJ 07825 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	862.1300   More FDA Info for this Regulation Number
Classification Product Code	CGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2000
Decision Date	01/12/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review