FDA 510(k) Application Details - K003204

Device Classification Name	Antisera, Cf, Influenza Virus A, B, C   More FDA Info for this Device
510(K) Number	K003204
Device Name	Antisera, Cf, Influenza Virus A, B, C
Applicant	INTRACEL CORP. 1330 PICCARD DR. ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	SHANE WARD Other 510(k) Applications for this Contact
Regulation Number	866.3330   More FDA Info for this Regulation Number
Classification Product Code	GNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2000
Decision Date	11/07/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review