LIAISON EA IGG

Epstein-barr Virus, Other

DIASORIN, INC.

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

Pre-market Notification Details

Device IDK060204
510k NumberK060204
Device Name:LIAISON EA IGG
ClassificationEpstein-barr Virus, Other
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
ContactDavid M Ikeda
Product CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-01-26
Decision Date2006-10-18
Summary:summary

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