FDA 510(k) Application Details - K080485

Device Classification Name	Nadh Oxidation/Nad Reduction, Ast/Sgot   More FDA Info for this Device
510(K) Number	K080485
Device Name	Nadh Oxidation/Nad Reduction, Ast/Sgot
Applicant	DIASYS DIAGNOSTICS SYSTEMS GMBH ALTE STRASSE 9 HOLZHEIM, RHEINLAND-PFALZ D-65558 DE Other 510(k) Applications for this Company
Contact	STEPHANIE KLEIN Other 510(k) Applications for this Contact
Regulation Number	862.1100   More FDA Info for this Regulation Number
Classification Product Code	CIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2008
Decision Date	12/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review