Cleared Traditional

ARCHITECT Toxo IgG

K210596 · Abbott Laboratories · Microbiology
May 2022
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K210596 is an FDA 510(k) clearance for the ARCHITECT Toxo IgG, 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 May 19, 2022, 444 days after receiving the submission on March 1, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K210596 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2021
Decision Date May 19, 2022
Days to Decision 444 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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