Cleared Traditional

THYROGLOBULIN ASSAY SYSTEM

K972190 · American Laboratory Products Co., Ltd. · Immunology
Jul 1997
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K972190 is an FDA 510(k) clearance for the THYROGLOBULIN ASSAY SYSTEM, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on July 14, 1997, 56 days after receiving the submission on May 19, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K972190 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1997
Decision Date July 14, 1997
Days to Decision 56 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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