WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5


Device Classification Name

azo dye, calcium

510(k) Number K021334
Device Name WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
Original Applicant
WIENER LABORATORIES S.A.I.C.
2944 riobamba
rosario, 

AR

2000

Original Contact viviana cetola
Regulation Number 862.1145
Classification Product Code
CJY  
Date Received 04/26/2002
Decision Date 09/10/2002
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