LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871

Reagent, Borrelia Serological Reagent

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Borrelia Igg/igm Assay, Model 310870; Serum Controls, Model 310871.

Pre-market Notification Details

Device IDK062473
510k NumberK062473
Device Name:LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871
ClassificationReagent, Borrelia Serological Reagent
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 CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-24
Decision Date2007-04-12
Summary:summary

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