Cleared Traditional

Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

K180202 · Immuno Concepts, N.A. , Ltd. · Immunology

Oct 2018

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K180202 is an FDA 510(k) clearance for the Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Immuno Concepts, N.A. , Ltd. (Sacramento, US). The FDA issued a Cleared decision on October 19, 2018, 268 days after receiving the submission on January 24, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K180202 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2018
Decision Date	October 19, 2018
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660