Cleared Traditional

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

K162678 · Roche Diagnostics · Microbiology
Jun 2017
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K162678 is an FDA 510(k) clearance for the Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on June 23, 2017, 270 days after receiving the submission on September 26, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K162678 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2016
Decision Date June 23, 2017
Days to Decision 270 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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