FDA 510(k) Application Details - K022962

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K022962
Device Name	Diazo Colorimetry, Bilirubin
Applicant	WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA ROSARIO 2000 AR Other 510(k) Applications for this Company
Contact	VIVIANA CETOLA Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	CIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2002
Decision Date	11/01/2002
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