FDA.reportPublic FDA data

510(k) K254059

Device
Access anti-HBc IgM
Applicant
Beckman Coulter, Inc.
510(k) number
K254059
Product code
SEI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-13
Date received
2025-12-17
Regulation
866.3173
Classification name
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Veronica Colinayo
Address
250 S. Kraemer Blvd. Brea CA US 92821 92821

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SEI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260046Elecsys Anti-HBc IIRoche Diagnostics2026-04-07
K260049Elecsys Anti-HBc IgMRoche Diagnostics2026-04-07
K253687Access anti-HBc TotalBeckman Coulter, Inc.2026-02-19