FDA 510(k) Application Details - K081064

Device Classification Name	Giardia Spp.   More FDA Info for this Device
510(K) Number	K081064
Device Name	Giardia Spp.
Applicant	IVD RESEARCH, INC. 5470 E. EDWIN RD. TUCSON, AZ 85739 US Other 510(k) Applications for this Company
Contact	MICHAEL WIENHOLT Other 510(k) Applications for this Contact
Regulation Number	866.3220   More FDA Info for this Regulation Number
Classification Product Code	MHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2008
Decision Date	01/14/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review