Cleared Traditional

K011201 - ALPCO MILENIA ANTI-TPO ELISA
(FDA 510(k) Clearance)

K011201 · American Laboratory Products Co., Ltd. · Immunology

May 2001

Decision

35d

Days

Class 2

Risk

K011201 is an FDA 510(k) clearance for the ALPCO MILENIA ANTI-TPO ELISA, 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 24, 2001, 35 days after receiving the submission on April 19, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number	K011201 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2001
Decision Date	May 24, 2001
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement