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510(k) K193532

Device
LIAISON Anti-HAV Assay
Applicant
DiaSorin Inc.
510(k) number
K193532
Product code
LOL  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-02
Date received
2019-12-20
Regulation
866.3310
Classification name
Hepatitis A Test (antibody And Igm Antibody)
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John C. Walter
Address
1951 Northwestern Ave. Stillwater MN US 55082 55082

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LOL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260048Elecsys Anti-HAV IgMRoche Diagnostics2026-04-07
K251995Access anti-HAV IgMBeckman Coulter, Inc.2026-01-27
K243846Access anti-HAVBeckman Coulter, Inc.2025-09-09
K222850HAVAb IgG IIAbbott Laboratories2023-08-10
K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.2022-12-09
K210272LIAISON Anti-HAVDiaSorin, Inc.2021-02-09
K190428Elecsys Anti-HAV IIRoche Diagnostics2019-08-13
K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.2016-10-13
K160650LIAISON HAV IgM, LIAISON Control HAV IgMDiaSorin, Inc.2016-08-25
K142758ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc.2014-12-05
K141116LIAISON XL ANALYZERDiaSorin, Inc.2014-07-25
K113704ARCHITECT HAVAB-GAbbott Laboratories2012-06-28
K103529LIAISON XL ANALYZER MODEL 10050DiaSorin, Inc.2011-01-21
K100903ANTI-HAVRoche Professional Diagnostics2010-10-05
K093955ANTI-HAV IGMRoche Diagnostics2010-06-22

Legacy Summary#

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FDA Review#

Decision Summary