LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Toxo Igm Ii, Liaison Control Toxo Igm Ii.

Pre-market Notification Details

Device IDK131441
510k NumberK131441
Device Name:LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
ContactSandra Zimniewicz
CorrespondentSandra Zimniewicz
DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-20
Decision Date2013-08-09
Summary:summary

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