FDA 510(k) Application Details - K050741

Device Classification Name	Radioimmunoassay, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K050741
Device Name	Radioimmunoassay, Human Chorionic Gonadotropin
Applicant	IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BC V3M 6S7 CA Other 510(k) Applications for this Company
Contact	JASON PENG Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	JHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2005
Decision Date	05/16/2005
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