FDA 510(k) Application Details - K081896

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K081896
Device Name	Labware, Assisted Reproduction
Applicant	BIOGENICS, INC. 2797 NAPA VALLEY CORPORATE DR. NAPA, CA 94558 US Other 510(k) Applications for this Company
Contact	LOU JONES Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2008
Decision Date	08/20/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review