FDA 510(k) Application Details - K022845

Device Classification Name	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus   More FDA Info for this Device
510(K) Number	K022845
Device Name	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Applicant	SA SCIENTIFIC, INC. 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	866.3480   More FDA Info for this Regulation Number
Classification Product Code	GQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2002
Decision Date	01/29/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review