FDA 510(k) Application Details - K103627

Device Classification Name	Enzyme Immunoassay, Carbamazepine   More FDA Info for this Device
510(K) Number	K103627
Device Name	Enzyme Immunoassay, Carbamazepine
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 9V6, AP6C-2 ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	JUDITH R WALLACH Other 510(k) Applications for this Contact
Regulation Number	862.3645   More FDA Info for this Regulation Number
Classification Product Code	KLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2010
Decision Date	10/14/2011
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