FDA 510(k) Application Details - K093879

Device Classification Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method   More FDA Info for this Device
510(K) Number	K093879
Device Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Applicant	ACON LABORATORIES, INC. 10125 MESA RIM RD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	RICHARD LENART Other 510(k) Applications for this Contact
Regulation Number	862.3040   More FDA Info for this Regulation Number
Classification Product Code	DIC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2009
Decision Date	08/06/2010
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