Cleared Traditional

LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II

K132234 · DiaSorin, Inc. · Microbiology
Aug 2013
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K132234 is an FDA 510(k) clearance for the LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on August 28, 2013, 41 days after receiving the submission on July 18, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K132234 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2013
Decision Date August 28, 2013
Days to Decision 41 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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