Cleared Traditional

Image Navigator by Immuno Concepts

K160265 · Immuno Concepts, N.A. , Ltd. · Immunology

Jun 2016

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K160265 is an FDA 510(k) clearance for the Image Navigator by Immuno Concepts, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Immuno Concepts, N.A. , Ltd. (Sacramento, US). The FDA issued a Cleared decision on June 17, 2016, 136 days after receiving the submission on February 2, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K160265 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2016
Decision Date	June 17, 2016
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100