FDA 510(k) Application Details - K020794

Device Classification Name	Colorimetry, Salicylate   More FDA Info for this Device
510(K) Number	K020794
Device Name	Colorimetry, Salicylate
Applicant	BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS Other 510(k) Applications for this Contact
Regulation Number	862.3830   More FDA Info for this Regulation Number
Classification Product Code	DKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2002
Decision Date	07/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review