FDA 510(k) Application Details - K061503

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K061503
Device Name	Calibrators, Drug Specific
Applicant	DADE BEHRING, INC. P.O. BOX 6101 MS 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	ANDREA M TASKER Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DLJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2006
Decision Date	06/22/2006
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