FDA 510(k) Application Details - K891093

Device Classification Name	Beta-Globulin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K891093
Device Name	Beta-Globulin, Antigen, Antiserum, Control
Applicant	E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 WILMINGTON, DE US Other 510(k) Applications for this Company
Contact	RICHARD M VAUGHT Other 510(k) Applications for this Contact
Regulation Number	866.5160   More FDA Info for this Regulation Number
Classification Product Code	DCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/1989
Decision Date	04/26/1989
Decision	SE - Substantially Equivalent
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review