WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254


Device Classification Name

enzyme linked immunosorbent assay, t. cruzi

510(k) Number K023889
Device Name WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
Original Applicant
WIENER LABORATORIES S.A.I.C.
2944 riobamba
rosario, 

AR

2000

Original Contact viviana cetola
Regulation Number 866.3870
Classification Product Code
MIU  
Date Received 11/21/2002
Decision Date 02/11/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No