Cleared Traditional

FREND Testosterone Test System

K153577 · Nanoentek USA, Inc. · Chemistry
Oct 2016
Decision
304d
Days
Class 1
Risk

About This 510(k) Submission

K153577 is an FDA 510(k) clearance for the FREND Testosterone Test System, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Nanoentek USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on October 14, 2016, 304 days after receiving the submission on December 15, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K153577 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2015
Decision Date October 14, 2016
Days to Decision 304 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680