FDA 510(k) Application Details - K961053

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Rubella   More FDA Info for this Device
510(K) Number	K961053
Device Name	Enzyme Linked Immunoabsorbent Assay, Rubella
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	866.3510   More FDA Info for this Regulation Number
Classification Product Code	LFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/1996
Decision Date	09/04/1996
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