Cleared Special

ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)

K062516 · Beckman Coulter, Inc. · Immunology
Oct 2006
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K062516 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS), 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 October 5, 2006, 38 days after receiving the submission on August 28, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K062516 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2006
Decision Date October 05, 2006
Days to Decision 38 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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