FDA 510(k) Application Details - K050625

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K050625
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant	SWEDEN DIAGNOSTICS (GERMANY) GMBH MUNZINGER STRASSE 7 FREIBURG D-79111 DE Other 510(k) Applications for this Company
Contact	SABINE KLUGBAUER 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	03/11/2005
Decision Date	04/26/2005
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