FDA 510(k) Application Details - K980666

Device Classification Name	Nadh Oxidation/Nad Reduction, Ast/Sgot   More FDA Info for this Device
510(K) Number	K980666
Device Name	Nadh Oxidation/Nad Reduction, Ast/Sgot
Applicant	SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. ST. LOUIS, MO 63103 US Other 510(k) Applications for this Company
Contact	WILLIAM R GILBERT 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	02/20/1998
Decision Date	03/20/1998
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