Cleared Traditional

Elecsys Anti-Tg

K222610 · Roche Diagnostics · Immunology
Sep 2023
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K222610 is an FDA 510(k) clearance for the Elecsys Anti-Tg, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on September 15, 2023, 382 days after receiving the submission on August 29, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K222610 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2022
Decision Date September 15, 2023
Days to Decision 382 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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