DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS

Test, Antigen, Nuclear, Epstein-barr Virus

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays.

Pre-market Notification Details

Device IDK040120
510k NumberK040120
Device Name:DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
ClassificationTest, Antigen, Nuclear, Epstein-barr Virus
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
ContactDavid M Ikeda
CorrespondentDavid M Ikeda
DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
Product CodeLLM  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-20
Decision Date2005-04-29
Summary:summary

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