Elecsys Anti-HBc II— 510(k) K260046
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K260046 for Elecsys Anti-HBc II, Substantially Equivalent on 2026-04-07. Applicant: Roche Diagnostics. Device class: 2.
Summary
Roche Diagnostics' Elecsys Anti-HBc II 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, and it came in as a Traditional 510(k).
Roche Diagnostics filed from Indianapolis, Indiana. The decision came 90 calendar days after FDA received it (January 7 to April 7, 2026).
Clearance details
- Applicant
- Roche Diagnostics
- 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
- Indianapolis, IN, US
Recent devices under product code SEI
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