FDA 510(k) Application Details - K062864

Device Classification Name	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies   More FDA Info for this Device
510(K) Number	K062864
Device Name	System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
Applicant	MAST GROUP LTD. MAST HOUSE, DERBY RD. BOOTLE, MERSEYSIDE L20 1EA GB Other 510(k) Applications for this Company
Contact	BARBARA A LEE Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	MYI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2006
Decision Date	10/18/2006
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