FDA 510(k) Application Details - K101564

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	K101564
Device Name	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. MAILSTOP C-12 ATLANTA, GA 30333 US Other 510(k) Applications for this Company
Contact	HYE-JOO KIM 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	06/04/2010
Decision Date	06/22/2010
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