FDA 510(k) Application Details - K982311

Device Classification Name	Antigen, Cf (Including Cf Control), Cytomegalovirus   More FDA Info for this Device
510(K) Number	K982311
Device Name	Antigen, Cf (Including Cf Control), Cytomegalovirus
Applicant	INTRACEL CORP. 1330 PICCARD DR. ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	FEDORA DAYE CONTRERAS Other 510(k) Applications for this Contact
Regulation Number	866.3175   More FDA Info for this Regulation Number
Classification Product Code	GQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/1998
Decision Date	12/14/1998
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