LIAISON Anti-HAV Assay

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.

Pre-market Notification Details

Device IDK193532
510k NumberK193532
Device Name:LIAISON Anti-HAV Assay
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant DiaSorin Inc. 1951 Northwestern Ave Stillwater,  MN  55082
ContactJohn C. Walter
CorrespondentMari Meyer
DiaSorin Inc. 1951 Northwestern Ave Stillwater,  MN  55082
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-03-02

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