FDA.reportPublic FDA data

510(k) K251995

Device
Access anti-HAV IgM
Applicant
Beckman Coulter, Inc.
510(k) number
K251995
Product code
LOL
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-27
Date received
2025-06-27
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
N

Applicant Contact#

Contact
Loretta Lydon O'Toole
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

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
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
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