FDA 510(k) Application Details - K121256

Device Classification Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method   More FDA Info for this Device
510(K) Number	K121256
Device Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Applicant	CHEMATICS, INC. P.O. BOX 293 HIGHWAY 13 SOUTH NORTH WEBSTER, IN 46555 US Other 510(k) Applications for this Company
Contact	CARL REYNOLDS 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	04/25/2012
Decision Date	09/12/2012
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