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510(k) K253687

Device
Access anti-HBc Total
Applicant
Beckman Coulter, Inc.
510(k) number
K253687
Product code
SEI
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-19
Date received
2025-11-21
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
Fatima Pacheco
Address
1000 Hazeltine Dr. Chaska MN US 55318 55318

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
K254059Access anti-HBc IgMBeckman Coulter, Inc.2026-03-13