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

Enzyme Linked Immunosorbent Assay, T. Cruzi

WIENER LABORATORIES S.A.I.C.

The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254.

Pre-market Notification Details

Device IDK023889
510k NumberK023889
Device Name:WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
ClassificationEnzyme Linked Immunosorbent Assay, T. Cruzi
Applicant WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario,  AR 2000
ContactViviana Cetola
CorrespondentViviana Cetola
WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario,  AR 2000
Product CodeMIU  
CFR Regulation Number866.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-21
Decision Date2004-02-11
Summary:summary

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