Cleared Traditional

THYRETAIN TM TSI REPORTER BIOASSAY

K092229 · Diagnostic Hybrids, Inc. · Immunology
May 2010
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K092229 is an FDA 510(k) clearance for the THYRETAIN TM TSI REPORTER BIOASSAY, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on May 18, 2010, 299 days after receiving the submission on July 23, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K092229 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2009
Decision Date May 18, 2010
Days to Decision 299 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

Similar Devices — JZO System, Test, Thyroid Autoantibody

All 91
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · Siemens Healthcare Diagnostics, Inc. · Oct 2025
Access TPO Antibody
K240469 · Beckman Coulter, Inc. · Aug 2024
Access Thyroglobulin Antibody II
K213517 · Beckman Coulter, Inc. · Sep 2023
Elecsys Anti-Tg
K222610 · Roche Diagnostics · Sep 2023
Elecsys Anti-TSHR
K193313 · Roche Diagnostics · Feb 2020
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K151799 · Phadia AB · Mar 2016