FDA 510(k) Application Details - K041165

Device Classification Name	Radioimmunoassay, Follicle-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K041165
Device Name	Radioimmunoassay, Follicle-Stimulating Hormone
Applicant	ACON LABORATORIES, INC. 163 CABOT ST. BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	FRAN WHITE 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	05/04/2004
Decision Date	06/17/2004
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