FDA 510(k) Application Details - K021393

Device Classification Name	Calibrators, Drug Mixture   More FDA Info for this Device
510(K) Number	K021393
Device Name	Calibrators, Drug Mixture
Applicant	QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. REDONDO BEACH, CA 90278-1205 US Other 510(k) Applications for this Company
Contact	GEBHARD NEYER Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2002
Decision Date	06/13/2002
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