FDA 510(k) Applications for Medical Device Product Code: LSW (Anti-Dna Antibody, Antigen And Control)

FDA 510(k) Applications for Medical Device Product Code "LSW"
(Anti-Dna Antibody, Antigen And Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K172348	Aesku Diagnostics GmbH & Co. KG	AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10	02/16/2018
K041628	AESKU.DIAGNOSTICS	AESKULISA DS DNA G	10/14/2004
K081251	AESKU.DIAGNOSTICS	MODIFICATION TO AESKULISA DS DNA G	05/13/2008
K060380	BIOMEDICAL DIAGNOSTICS (BMD) SA	FIDIS DSDNA	05/02/2006
K152013	INOVA DIAGNOSTICS, INC.	QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls	04/11/2016
K072393	PHADIA US INC.	ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01	12/07/2007