FDA 510(k) Application Details - K964385

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K964385
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant	ELIAS USA, INC. 373 280TH ST. OSCEOLA, WI 54020 US Other 510(k) Applications for this Company
Contact	GOTTFRIED KELLERMANN, PH.D. Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1996
Decision Date	03/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review