Cleared Traditional

EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE

K141827 · Euroimmun Us, Inc. · Immunology

Apr 2015

Decision

284d

Days

Class 2

Risk

About This 510(k) Submission

K141827 is an FDA 510(k) clearance for the EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Euroimmun Us, Inc. (Morris Plains, US). The FDA issued a Cleared decision on April 17, 2015, 284 days after receiving the submission on July 7, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K141827 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2014
Decision Date	April 17, 2015
Days to Decision	284 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