Elecsys Anti-HAV IgM— 510(k) K260048
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K260048 for Elecsys Anti-HAV IgM, Substantially Equivalent on 2026-04-07. Applicant: Roche Diagnostics. Device class: 2.
Summary
Roche Diagnostics' Elecsys Anti-HAV IgM is filed under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)).
Class II, 21 CFR 866.3310. It came in as a Traditional 510(k), and Microbiology is both the classification panel and the review panel.
Roche Diagnostics filed from Indianapolis (the record lists the state as IL). Review took 90 calendar days (January 7 to April 7, 2026).
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Product code LOL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3310
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IL, US
Recent devices under product code LOL
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