Access anti-HBc IgM— 510(k) K254059
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K254059 for Access anti-HBc IgM, Substantially Equivalent on 2026-03-13. Applicant: Beckman Coulter, Inc.. Device class: 2.
Summary
Beckman Coulter's Access anti-HBc IgM is filed under 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, and it came in as a Traditional 510(k).
Beckman Coulter filed from Brea, California. Review took 86 calendar days (December 17, 2025 to March 13, 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
- Brea, CA, US
Recent devices under product code SEI
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