FDA 510(k) Application Details - K083724

Device Classification Name	Blood, Occult, Colorimetric, In Urine   More FDA Info for this Device
510(K) Number	K083724
Device Name	Blood, Occult, Colorimetric, In Urine
Applicant	WIENER LABORATORIOS S.A.I.C. 2944 RIOBAMBA ROSARIO 2000 AR Other 510(k) Applications for this Company
Contact	VIVINA CETOLA Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	JIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2008
Decision Date	09/02/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review