Access anti-HBc Total— 510(k) K253687
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K253687 for Access anti-HBc Total, Substantially Equivalent on 2026-02-19. Applicant: Beckman Coulter, Inc.. Device class: 2.
Summary
Beckman Coulter's Access anti-HBc Total is filed under product code SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays). The record doesn't describe the assay beyond its name and that code name.
Class II, 21 CFR 866.3173. Microbiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Beckman Coulter filed from Chaska, Minnesota. FDA found it substantially equivalent 90 calendar days after receipt (November 21, 2025 to February 19, 2026).
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Product code SEI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3173
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code SEI
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