FDA 510(k) Application Details - K031059

Device Classification Name	Cryptosporidium Spp.   More FDA Info for this Device
510(K) Number	K031059
Device Name	Cryptosporidium Spp.
Applicant	IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	DAVE LAMBILLOTTE Other 510(k) Applications for this Contact
Regulation Number	866.3220   More FDA Info for this Regulation Number
Classification Product Code	MHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2003
Decision Date	07/10/2003
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	Y
Expedited Review