FDA 510(k) Application Details - K020576

Device Classification Name	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species   More FDA Info for this Device
510(K) Number	K020576
Device Name	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Applicant	ID BIOMEDICAL CORP. 19204 N. CREEK PKWAY., STE 100 BOTHELL, WA 98011 US Other 510(k) Applications for this Company
Contact	DAVID CLARY Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NIJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2002
Decision Date	05/01/2002
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