FDA 510(k) Application Details - K102170

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K102170
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST CYPRESS, CA 90630 US Other 510(k) Applications for this Company
Contact	TARA VIVIANI Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2010
Decision Date	11/24/2010
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