LFX · Class II · 21 CFR 866.3510

FDA Product Code LFX: Enzyme Linked Immunoabsorbent Assay, Rubella

Leading manufacturers include Abbott Laboratories and Beckman Coulter, Inc..

2
Total
2
Cleared
263d
Avg days
2025
Since

List of Enzyme Linked Immunoabsorbent Assay, Rubella devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Nov 17, 2025
Access Rubella IgG
K250588
Beckman Coulter, Inc.
Microbiology · 263d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168
Abbott Laboratories
Microbiology · 263d

How to use this database

This page lists all FDA 510(k) submissions for Enzyme Linked Immunoabsorbent Assay, Rubella devices (product code LFX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →