FDA 510(k) Application Details - K081231

Device Classification Name	Enzyme Immunoassay, Phenobarbital   More FDA Info for this Device
510(K) Number	K081231
Device Name	Enzyme Immunoassay, Phenobarbital
Applicant	ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 049D BLDG. AP 6C-2 ABBOTT PARK, IL 60064-6092 US Other 510(k) Applications for this Company
Contact	CAROL JOCHUM Other 510(k) Applications for this Contact
Regulation Number	862.3660   More FDA Info for this Regulation Number
Classification Product Code	DLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2008
Decision Date	09/26/2008
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