FDA 510(k) Application Details - K011112

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K011112
Device Name	Calibrators, Drug Specific
Applicant	DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY NEWARK,, DE 19714 US Other 510(k) Applications for this Company
Contact	LORRAINE H PIESTRAK 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	04/11/2001
Decision Date	07/17/2001
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