LSW · Class II · 21 CFR 866.5100

FDA Product Code LSW: Anti-dna Antibody, Antigen And Control

Leading manufacturers include Aesku Diagnostics, Aesku.Diagnostics GmbH & Co. KG and Immco Diagnostics, Inc..

8
Total
8
Cleared
152d
Avg days
1987
Since

FDA 510(k) Cleared Anti-dna Antibody, Antigen And Control Devices (Product Code LSW)

8 devices
1–8 of 8
Cleared Feb 16, 2018
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
Immunology · 197d
Cleared Apr 11, 2016
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
K152013
Inova Diagnostics, Inc.
Immunology · 265d
Cleared May 13, 2008
MODIFICATION TO AESKULISA DS DNA G
K081251
Aesku Diagnostics
Immunology · 11d
Cleared Dec 07, 2007
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393
Phadia US, Inc.
Immunology · 102d
Cleared May 02, 2006
FIDIS DSDNA
K060380
Biomedical Diagnostics (Bmd) SA
Immunology · 77d
Cleared Oct 14, 2004
AESKULISA DS DNA G
K041628
Aesku Diagnostics
Immunology · 120d
Cleared Mar 22, 1993
ANTI-DSDNA ANTIBODY TEST
K921658
Immco Diagnostics, Inc.
Immunology · 349d

About Product Code LSW - Regulatory Context