WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K030482
Device Name WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
Applicant
WIENER LABORATORIES
2944 riobamba
rosario, 

AR

2000

Applicant Contact viviana cetola
Correspondent
WIENER LABORATORIES
2944 riobamba
rosario, 

AR

2000

Correspodent Contact viviana cetola
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 02/13/2003
Decision Date 03/19/2003
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