WIENER LAB. BILIRUBINA DIRECT AA


Device Classification Name

diazo colorimetry, bilirubin

510(k) Number K024116
Device Name WIENER LAB. BILIRUBINA DIRECT AA
Original Applicant
WIENER LABORATORIES S.A.I.C.
2944 riobamba
rosario, 

AR

2000

Original Contact viviana cetila
Regulation Number 862.1110
Classification Product Code
CIG  
Date Received 12/13/2002
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No