WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K024305
Device Name WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
Original Applicant
WIENER LABORATORIES S.A.I.C.
2944 riobamba
rosario, 

AR

2000

Original Contact viviana cetola
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 12/24/2002
Decision Date 03/18/2003
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