WIENER LAB GOT (AST) UV AA LIQUIDA


Device Classification Name

nadh oxidation/nad reduction, ast/sgot

510(k) Number K023551
Device Name WIENER LAB GOT (AST) UV AA LIQUIDA
Original Applicant
WIENER LABORATORIES S.A.I.C.
2944 riobamba
rosario, santa fe, 

AR

2000

Original Contact viviana cetola
Regulation Number 862.1100
Classification Product Code
CIT  
Date Received 10/22/2002
Decision Date 12/09/2002
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