FDA 510(k) Application Details - K991274

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Mumps Virus   More FDA Info for this Device
510(K) Number	K991274
Device Name	Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Applicant	COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 COLUMBIA, MD 21045 US Other 510(k) Applications for this Company
Contact	NORMAN JENKINS Other 510(k) Applications for this Contact
Regulation Number	866.3380   More FDA Info for this Regulation Number
Classification Product Code	LJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/1999
Decision Date	09/03/1999
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