FDA 510(k) Application Details - K052662

Device Classification Name	Radioimmunoassay, Follicle-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K052662
Device Name	Radioimmunoassay, Follicle-Stimulating Hormone
Applicant	IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, B.C. V3M 6S7 CA Other 510(k) Applications for this Company
Contact	JASON PENG 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	09/27/2005
Decision Date	11/30/2005
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