LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV

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 Anti-hav Assay, Liaison Control Anti-hav.

Pre-market Notification Details

Device IDK082049
510k NumberK082049
Device Name:LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
ContactCarol A Depouw
CorrespondentCarol A Depouw
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 Received2008-07-18
Decision Date2008-12-05
Summary:summary

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