FDA 510(k) Application Details - K013538

Device Classification Name	Nad-Nadh, Specific Reagent For Alcohol Enzyme Method   More FDA Info for this Device
510(K) Number	K013538
Device Name	Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Applicant	ABBOTT LABORATORIES 1920 HURD DRIVE, MS 8-21 IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	ALICIA SIMPSON Other 510(k) Applications for this Contact
Regulation Number	862.3040   More FDA Info for this Regulation Number
Classification Product Code	DML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2001
Decision Date	12/14/2001
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