FDA 510(k) Application Details - K010812

Device Classification Name	Enzyme Immunoassay, Procainamide   More FDA Info for this Device
510(K) Number	K010812
Device Name	Enzyme Immunoassay, Procainamide
Applicant	SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD SAN JOSE, CA 95135 US Other 510(k) Applications for this Company
Contact	VIRGINIA SINGER Other 510(k) Applications for this Contact
Regulation Number	862.3320   More FDA Info for this Regulation Number
Classification Product Code	LAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2001
Decision Date	04/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review