FDA 510(k) Application Details - K023550

Device Classification Name	Acid, Uric, Uricase (Colorimetric)   More FDA Info for this Device
510(K) Number	K023550
Device Name	Acid, Uric, Uricase (Colorimetric)
Applicant	WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA ROSARIO, SANTA FE 2000 AR Other 510(k) Applications for this Company
Contact	VIVIANA CETOLA Other 510(k) Applications for this Contact
Regulation Number	862.1775   More FDA Info for this Regulation Number
Classification Product Code	KNK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2002
Decision Date	12/09/2002
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