FDA 510(k) Application Details - K012318

Device Classification Name	Calibrators, Drug Mixture   More FDA Info for this Device
510(K) Number	K012318
Device Name	Calibrators, Drug Mixture
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, CO. ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	P ARMSTRONG 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	07/23/2001
Decision Date	09/12/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review