FDA 510(k) Application Details - K033278

Device Classification Name	Acid, Uric, Uricase (U.V.)   More FDA Info for this Device
510(K) Number	K033278
Device Name	Acid, Uric, Uricase (U.V.)
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	LYNNE HAMILTON 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	10/10/2003
Decision Date	02/27/2004
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