Cleared Traditional

Alinity i Rubella IgG

K243168 · Abbott Laboratories · Microbiology
Jun 2025
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K243168 is an FDA 510(k) clearance for the Alinity i Rubella IgG, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 20, 2025, 263 days after receiving the submission on September 30, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K243168 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date June 20, 2025
Days to Decision 263 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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