LIAISON XL ANALYZER

Hepatitis A Test (antibody And Igm Antibody)

DIASORIN, INC.

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

Pre-market Notification Details

Device IDK141116
510k NumberK141116
Device Name:LIAISON XL ANALYZER
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
ContactMari Meyer
CorrespondentMari Meyer
DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-30
Decision Date2014-07-25
Summary:summary

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