LIAISON XL ANALYZER MODEL 10050

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 Model 10050.

Pre-market Notification Details

Device IDK103529
510k NumberK103529
Device Name:LIAISON XL ANALYZER MODEL 10050
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant DIASORIN, INC. 195 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
ContactMari Meyer
CorrespondentMari Meyer
DIASORIN, INC. 195 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-01
Decision Date2011-01-21
Summary:summary

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