FDA 510(k) Application Details - K031834

Device Classification Name	Giardia Spp.   More FDA Info for this Device
510(K) Number	K031834
Device Name	Giardia Spp.
Applicant	REMEL INC 12076 SANTA FE DRIVE LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	EARLEEN C PARKS 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	06/13/2003
Decision Date	11/10/2003
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	N
Expedited Review