FDA 510(k) Application Details - K092423

Device Classification Name	More FDA Info for this Device
510(K) Number	K092423
Device Name	XPECT FLU A & B
Applicant	Thermo Fisher Scientific 12150 SANTA FE DRIVE LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	MARY A SILVIUS 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	08/07/2009
Decision Date	08/26/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review