Cleared Traditional

Access Toxo IgG

K242022 · Beckman Coulter, Inc. · Microbiology
Mar 2025
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K242022 is an FDA 510(k) clearance for the Access Toxo IgG, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on March 28, 2025, 260 days after receiving the submission on July 11, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K242022 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2024
Decision Date March 28, 2025
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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