Cleared Traditional

FREND PSA PLUS (reagent cartridge)

K162378 · Nanoentek USA, Inc. · Immunology

May 2017

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K162378 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 USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 17, 2017, 266 days after receiving the submission on August 24, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K162378 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2016
Decision Date	May 17, 2017
Days to Decision	266 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