FDA 510(k) Application Details - K974002

Device Classification Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method   More FDA Info for this Device
510(K) Number	K974002
Device Name	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Applicant	DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, CHARLOTTETOWN, P.E.I. C1E 2A6 CA Other 510(k) Applications for this Company
Contact	KAREN CALLBECK 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	10/21/1997
Decision Date	04/01/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review