FDA 510(k) Application Details - K971485

Device Classification Name	Acid, Uric, Uricase (U.V.)   More FDA Info for this Device
510(K) Number	K971485
Device Name	Acid, Uric, Uricase (U.V.)
Applicant	TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	DAVID JOHNSON Other 510(k) Applications for this Contact
Regulation Number	862.1775   More FDA Info for this Regulation Number
Classification Product Code	CDO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/1997
Decision Date	05/27/1997
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