FDA.reportPublic FDA data

510(k) K210272

Device
LIAISON Anti-HAV
Applicant
DiaSorin, Inc.
510(k) number
K210272
Product code
LOL
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-09
Date received
2021-02-01
Regulation
866.3310
Classification name
Hepatitis A Test (Antibody And Igm Antibody)
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John C. Walker
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
K193532LIAISON Anti-HAV AssayDiaSorin, Inc.2020-03-02
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