Cleared Traditional

AESKUSLIDES ANA HEP-2

K120889 · Aesku Diagnostics · Immunology

Oct 2012

Decision

206d

Days

Class 2

Risk

About This 510(k) Submission

K120889 is an FDA 510(k) clearance for the AESKUSLIDES ANA HEP-2, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Aesku Diagnostics (Pedricktown, US). The FDA issued a Cleared decision on October 15, 2012, 206 days after receiving the submission on March 23, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K120889 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2012
Decision Date	October 15, 2012
Days to Decision	206 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