WIENER LAB COLINESTERASA AA


Device Classification Name

colorimetry, cholinesterase

510(k) Number K023992
Device Name WIENER LAB COLINESTERASA AA
Original Applicant
WIENER LABORATORIES S.A.I.C.
2571 maipu
rosario, santa fe, 

AR

2000

Original Contact viviana cetola
Regulation Number 862.3240
Classification Product Code
DIH  
Date Received 12/02/2002
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No