FDA 510(k) Application Details - K973869

Device Classification Name	Nadh Oxidation/Nad Reduction, Alt/Sgpt   More FDA Info for this Device
510(K) Number	K973869
Device Name	Nadh Oxidation/Nad Reduction, Alt/Sgpt
Applicant	TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	David Johnston Other 510(k) Applications for this Contact
Regulation Number	862.1030   More FDA Info for this Regulation Number
Classification Product Code	CKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/1997
Decision Date	01/07/1998
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