WIENER LAB AMILASA 405 AA LIQUIDA


Device Classification Name

catalytic methods, amylase

510(k) Number K023549
Device Name WIENER LAB AMILASA 405 AA LIQUIDA
Original Applicant
WIENER LABORATORIES S.A.I.C.
2944 riobamba
rosario, santa fe, 

AR

2000

Original Contact viviana cetola
Regulation Number 862.1070
Classification Product Code
JFJ  
Date Received 10/22/2002
Decision Date 12/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No