FDA 510(k) Application Details - K053108

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K053108
Device Name	Calibrators, Drug Specific
Applicant	DADE BEHRING, INC. P.O. BOX 6101, M/S 514 NEWARK, DE 19702 US Other 510(k) Applications for this Company
Contact	YUK-TING LEWIS 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	11/04/2005
Decision Date	02/16/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review