FDA 510(k) Application Details - K092349

Device Classification Name	More FDA Info for this Device
510(K) Number	K092349
Device Name	CLEARVIEW EXACT II INFLUENZA A & B TEST
Applicant	INVERNESS MEDICAL, INC. 10 Southgate Road Scarborough, ME 04074 US Other 510(k) Applications for this Company
Contact	Anne Jepson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2009
Decision Date	05/10/2010
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