FDA 510(k) Application Details - K930422

Device Classification Name	Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K930422
Device Name	Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	ELIAS USA, INC. 373 280TH ST. OSCEOLA, WI US Other 510(k) Applications for this Company
Contact	GOTTFRIED KELLERMANN Other 510(k) Applications for this Contact
Regulation Number	866.5110   More FDA Info for this Regulation Number
Classification Product Code	DBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/1993
Decision Date	08/03/1993
Decision	SE - Substantially Equivalent
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review