FDA 510(k) Application Details - K983762

Device Classification Name	Antisera, Conjugated Fluorescent, Cytomegalovirus   More FDA Info for this Device
510(K) Number	K983762
Device Name	Antisera, Conjugated Fluorescent, Cytomegalovirus
Applicant	ORGANON TEKNIKA CORP. 100 AKZO AVE. DURHAM, NC 27712 US Other 510(k) Applications for this Company
Contact	RON SANYAL Other 510(k) Applications for this Contact
Regulation Number	866.3175   More FDA Info for this Regulation Number
Classification Product Code	LIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/1998
Decision Date	09/15/1999
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