Cleared Traditional

Alinity i Toxo IgM

K233932 · Abbott Laboratories · Microbiology
Aug 2024
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K233932 is an FDA 510(k) clearance for the Alinity i Toxo IgM, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 30, 2024, 260 days after receiving the submission on December 14, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K233932 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2023
Decision Date August 30, 2024
Days to Decision 260 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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