FDA 510(k) Application Details - K061496

Device Classification Name	Legionella, Spp., Elisa   More FDA Info for this Device
510(K) Number	K061496
Device Name	Legionella, Spp., Elisa
Applicant	SA SCIENTIFIC LTD. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US Other 510(k) Applications for this Company
Contact	RICARDO R MARTINEZ Other 510(k) Applications for this Contact
Regulation Number	866.3300   More FDA Info for this Regulation Number
Classification Product Code	MJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2006
Decision Date	06/28/2007
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