FREND™ Free T4 Test System

FDA 510(k) K152422 · Nanoentek USA, Inc.

Substantially Equivalent

510(k) numberK152422

Submission

Device name
FREND™ Free T4 Test System
Applicant
Nanoentek USA, Inc.
Pleasanton, CA, US
Received
August 26, 2015
Decision date
February 17, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CEC – Radioimmunoassay, Free Thyroxine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1695
Specialty
Clinical Chemistry

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K173122Abbott Architect Free T4CEC · Special Abbott Laboratories10/27/2017SE
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K131244Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional Roche Diagnostics01/27/2014SE
K132249Advia Centaur FT4, Advia Centaur T4CEC · Traditional Siemens Healthcare Diagnostics, Inc.09/13/2013SE

More from Siemens Healthcare Diagnostics, Inc.

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K162378FREND PSA PLUS (reagent cartridge)LTJ · Traditional 05/17/2017SE
K162754FREND Vitamin D Test SystemMRG · Traditional 01/12/2017SE
K153577FREND Testosterone Test SystemCDZ · Traditional 10/14/2016SE
K131928Frend TSH (Reagent Cartridge)JLW · Traditional 03/14/2014SE

Questions and answers

When was FREND™ Free T4 Test System cleared by the FDA?

FREND™ Free T4 Test System (K152422) received a 510(k) decision of Substantially Equivalent on February 17, 2016, 175 days after the submission was received.

What is the product code of K152422?

The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.