LIAISON HAV IgM, LIAISON Control HAV IgM

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 Hav Igm, Liaison Control Hav Igm.

Pre-market Notification Details

Device IDK160650
510k NumberK160650
Device Name:LIAISON HAV IgM, LIAISON Control HAV IgM
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant DiaSorin Inc. 1951 Northwestern Avenue Stillwater,  MN  55082 -0285
ContactJohn Walter
CorrespondentCarol A. Depouw
DiaSorin Inc. 1951 Northwestern Avenue Stillwater,  MN  55082 -0285
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-08
Decision Date2016-08-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.