LSW · Class II · 21 CFR 866.5100

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

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

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

About Product Code LSW - Regulatory Context