Cleared Traditional

Access Toxo IgM II

K242095 · Beckman Coulter, Inc. · Microbiology
Oct 2024
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K242095 is an FDA 510(k) clearance for the Access Toxo IgM II, 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 October 11, 2024, 86 days after receiving the submission on July 17, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K242095 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2024
Decision Date October 11, 2024
Days to Decision 86 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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