FDA 510(k) Application Details - K972720

Device Classification Name	Radioimmunoassay, Follicle-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K972720
Device Name	Radioimmunoassay, Follicle-Stimulating Hormone
Applicant	MONOBIND 729 WEST 16TH ST., C-4 COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	FREDERICK R JEROME 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	07/21/1997
Decision Date	09/02/1997
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