FDA 510(k) Application Details - K980391

Device Classification Name	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control   More FDA Info for this Device
510(K) Number	K980391
Device Name	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
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	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LRM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/1998
Decision Date	04/24/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review