FDA 510(k) Application Details - K010488

Device Classification Name	Nadh Oxidation/Nad Reduction, Ast/Sgot   More FDA Info for this Device
510(K) Number	K010488
Device Name	Nadh Oxidation/Nad Reduction, Ast/Sgot
Applicant	ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING 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	02/20/2001
Decision Date	04/09/2001
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