Cleared Traditional

ALPCO MILENIA ANTI-TG EIA

K011415 · American Laboratory Products Co., Ltd. · Immunology
May 2001
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K011415 is an FDA 510(k) clearance for the ALPCO MILENIA ANTI-TG EIA, 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 May 30, 2001, 22 days after receiving the submission on May 8, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K011415 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2001
Decision Date May 30, 2001
Days to Decision 22 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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