Cleared Traditional

IFA 40: HEP-20-10

K131791 · Euroimmun US · Immunology

Feb 2014

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K131791 is an FDA 510(k) clearance for the IFA 40: HEP-20-10, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on February 26, 2014, 253 days after receiving the submission on June 18, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K131791 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2013
Decision Date	February 26, 2014
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

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