Cleared Special

Abbott Architect Free T4

K173122 · Abbott Laboratories · Chemistry

Oct 2017

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K173122 is an FDA 510(k) clearance for the Abbott Architect Free T4, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Abbott Laboratories (Abbot Park, US). The FDA issued a Cleared decision on October 27, 2017, 28 days after receiving the submission on September 29, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K173122 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	October 27, 2017
Days to Decision	28 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF