FDA 510(k) Application Details - K080380

Device Classification Name	More FDA Info for this Device
510(K) Number	K080380
Device Name	SAS INFLUENZA A & B TEST
Applicant	SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US Other 510(k) Applications for this Company
Contact	ROBBI PERRY 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	02/13/2008
Decision Date	07/23/2009
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