FDA 510(k) Application Details - K980059

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Mumps Virus   More FDA Info for this Device
510(K) Number	K980059
Device Name	Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Applicant	QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US Other 510(k) Applications for this Company
Contact	ROBERT A CORT 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	01/07/1998
Decision Date	04/23/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review