Elecsys Anti-HAV IgM— 510(k) K260048

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K260048 for Elecsys Anti-HAV IgM, Substantially Equivalent on 2026-04-07. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LOL
Device class: Class 2
Regulation: 21 CFR 866.3310
Advisory panel: Microbiology
Date received: 2026-01-07
Decision date: 2026-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOL

K251995 — Access anti-HAV IgM2026-01-27
K243846 — Access anti-HAV2025-09-09
K222850 — HAVAb IgG II2023-08-10
K223403 — LIAISON Anti-HAV; LIAISON XS2022-12-09
K210272 — LIAISON Anti-HAV2021-02-09

More clearances from Roche Diagnostics

K261686 — Elecsys Phospho-Tau (217P) Plasma2026-08-19
K252323 — cobas pulse blood glucose monitoring system2026-06-12
K252280 — Elecsys Anti-SARS-CoV-2 S2026-04-13
K260046 — Elecsys Anti-HBc II2026-04-07
K260049 — Elecsys Anti-HBc IgM2026-04-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.