Cleared Special

ACCESS THYROGLOBULIN ANITBODY

K112933 · Beckman Coulter, Inc. · Immunology
Dec 2011
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K112933 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN ANITBODY, a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 27, 2011, 85 days after receiving the submission on October 3, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K112933 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2011
Decision Date December 27, 2011
Days to Decision 85 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JNL — Immunochemical, Thyroglobulin Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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