Cleared Traditional

FREND? Free T4 Test System

K152422 · Nanoentek USA, Inc. · Chemistry

Feb 2016

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K152422 is an FDA 510(k) clearance for the FREND? Free T4 Test System, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Nanoentek USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 17, 2016, 175 days after receiving the submission on August 26, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K152422 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2015
Decision Date	February 17, 2016
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF