Cleared Traditional

AESKULISA DS DNA G

K041628 · Aesku Diagnostics · Immunology
Oct 2004
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K041628 is an FDA 510(k) clearance for the AESKULISA DS DNA G, a Anti-dna Antibody, Antigen And Control (Class II — Special Controls, product code LSW), submitted by Aesku Diagnostics (Miami, US). The FDA issued a Cleared decision on October 14, 2004, 120 days after receiving the submission on June 16, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K041628 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2004
Decision Date October 14, 2004
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LSW — Anti-dna Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LSW Anti-dna Antibody, Antigen And Control

All 7
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
K172348 · Aesku.Diagnostics GmbH & Co. KG · Feb 2018
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
K152013 · Inova Diagnostics, Inc. · Apr 2016
MODIFICATION TO AESKULISA DS DNA G
K081251 · Aesku Diagnostics · May 2008
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · Phadia US, Inc. · Dec 2007
FIDIS DSDNA
K060380 · Biomedical Diagnostics (Bmd) SA · May 2006
ANTI-DSDNA ANTIBODY TEST
K921658 · Immco Diagnostics, Inc. · Mar 1993