FDA 510(k) Application Details - K021687

Device Classification Name	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus   More FDA Info for this Device
510(K) Number	K021687
Device Name	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Applicant	BINAX, INC. 217 READ ST. PORTLAND, ME 04103 US Other 510(k) Applications for this Company
Contact	Anne Jepson 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	05/22/2002
Decision Date	09/13/2002
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