Cleared Traditional

THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120

K090760 · Theratest Laboratories, Inc. · Immunology
Sep 2009
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K090760 is an FDA 510(k) clearance for the THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on September 3, 2009, 164 days after receiving the submission on March 23, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K090760 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2009
Decision Date September 03, 2009
Days to Decision 164 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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