Elecsys EBV IgM— 510(k) K260233

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K260233 for Elecsys EBV IgM, Substantially Equivalent on 2026-10-02. Applicant: Roche Diagnostics. Device class: 1.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LJN
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2026-01-26
Decision date: 2026-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJN

K123021 — BIOPLEX 2200 EBV IGM KIT2012-11-02
K073381 — PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M2008-08-04
K042092 — ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM2005-04-12
K033780 — MODIFICATION TO SERAQUEST VCA IGM2004-01-15
K990977 — SERAQUEST EB VAC IGM1999-10-06

More clearances from Roche Diagnostics

K260221 — Elecsys EBV EBNA IgG2026-10-02
K260232 — Elecsys EBV VCA IgG2026-10-02
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

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