FDA 510(k) Application Details - K092784

Device Classification Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast   More FDA Info for this Device
510(K) Number	K092784
Device Name	Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Applicant	ADVANDX, INC. 10A ROESSLER ROAD WOBURN, MA 01801 US Other 510(k) Applications for this Company
Contact	HENRIK STENDER Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	NZS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2009
Decision Date	03/12/2010
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