COPALIS EBV-M ANTIBODY ASSAY

Antibody Igm, If, Epstein-barr Virus

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Copalis Ebv-m Antibody Assay.

Pre-market Notification Details

Device IDK991459
510k NumberK991459
Device Name:COPALIS EBV-M ANTIBODY ASSAY
ClassificationAntibody Igm, If, Epstein-barr Virus
Applicant DIASORIN, INC. 9175 GUIFORD RD. Columbia,  MD  21046
ContactJudith J Smith
Product CodeLJN  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-04-26
Decision Date1999-05-14
Summary:summary

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