FDA 510(k) Application Details - K981650

Device Classification Name	Nadh Oxidation/Nad Reduction, Ast/Sgot   More FDA Info for this Device
510(K) Number	K981650
Device Name	Nadh Oxidation/Nad Reduction, Ast/Sgot
Applicant	TECO DIAGNOSTICS 4925 EAST HUNTER AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	RHODA FILIPINA 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	05/11/1998
Decision Date	06/29/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review