DIASORIN LIAISON TREPONEMA ASSAY

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Diasorin Liaison Treponema Assay.

Pre-market Notification Details

Device IDK061247
510k NumberK061247
Device Name:DIASORIN LIAISON TREPONEMA ASSAY
ClassificationEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
ContactCarol A Depouw
CorrespondentCarol A Depouw
DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
Product CodeLIP  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-03
Decision Date2006-07-31
Summary:summary

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