Cleared Traditional

K221890 - Elecsys Tg II (FDA 510(k) Clearance)

K221890 · Roche Diagnostics · Immunology device

Sep 2023

Decision

458d

Days

Class 2

Risk

K221890 is an FDA 510(k) clearance for the Elecsys Tg II. This device is classified as a System, Test, Thyroglobulin (Class II - Special Controls, product code MSW).

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 30, 2023, 458 days after receiving the submission on June 29, 2022.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K221890 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 29, 2022
Decision Date	September 30, 2023
Days to Decision	458 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF