FDA 510(k) Application Details - K080094

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K080094
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) 3131 WEST ROYAL LANE IRVING, TX 75063 US Other 510(k) Applications for this Company
Contact	STEPHANIE DONNELLY Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2008
Decision Date	09/03/2008
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