FDA 510(k) Application Details - K092166

Device Classification Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus   More FDA Info for this Device
510(K) Number	K092166
Device Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Applicant	ADVANDX, INC. 10A ROESSLER ROAD WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	PAULA E BULGER Other 510(k) Applications for this Contact
Regulation Number	866.3700   More FDA Info for this Regulation Number
Classification Product Code	NXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2009
Decision Date	11/23/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review