FDA 510(k) Application Details - K100148

Device Classification Name	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification   More FDA Info for this Device
510(K) Number	K100148
Device Name	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
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	866.3332   More FDA Info for this Regulation Number
Classification Product Code	OQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2010
Decision Date	05/24/2010
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