Elecsys Anti-HBc IgM— 510(k) K260049
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K260049 for Elecsys Anti-HBc IgM, Substantially Equivalent on 2026-04-07. Applicant: Roche Diagnostics. Device class: 2.
Summary
Elecsys Anti-HBc IgM is a Roche Diagnostics assay filed under product code SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays).
Class II, 21 CFR 866.3173. Microbiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Roche Diagnostics filed from Indianapolis, Indiana. The record shows 90 calendar days from receipt to decision (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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