Cleared Traditional

AESKULISA ENA 6 S

K041753 · Aesku Diagnostics · Immunology
Jul 2004
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K041753 is an FDA 510(k) clearance for the AESKULISA ENA 6 S, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Aesku Diagnostics (Miami, US). The FDA issued a Cleared decision on July 14, 2004, 15 days after receiving the submission on June 29, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K041753 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2004
Decision Date July 14, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

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