Cleared Traditional

FREND PSA PLUS (REAGENT CARTRIDGE)

K124056 · Nanoentek, Inc. · Immunology

May 2013

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K124056 is an FDA 510(k) clearance for the FREND PSA PLUS (REAGENT CARTRIDGE), a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Nanoentek, Inc. (Oxford, US). The FDA issued a Cleared decision on May 29, 2013, 149 days after receiving the submission on December 31, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K124056 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2012
Decision Date	May 29, 2013
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6010