Cleared Traditional

AESKULISA ANA HEP-2, REF 30-7115US

K081104 · Aesku Diagnostics · Immunology
May 2008
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K081104 is an FDA 510(k) clearance for the AESKULISA ANA HEP-2, REF 30-7115US, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Aesku Diagnostics (Wendelsheim, Rheinland, DE). The FDA issued a Cleared decision on May 2, 2008, 14 days after receiving the submission on April 18, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K081104 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2008
Decision Date May 02, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

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