FDA 510(k) Applications for Medical Device Product Code: KTL (Anti-Dna Indirect Immunofluorescent Solid Phase)

FDA 510(k) Applications for Medical Device Product Code "KTL"
(Anti-Dna Indirect Immunofluorescent Solid Phase)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K172244	Euroimmun US, Inc.	EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern	04/20/2018
K172252	Euroimmun US, Inc.	EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern	04/20/2018
K203599	Immuno Concepts N.A., Ltd.	Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System	05/26/2023
K013432	IMMUNO CONCEPTS, INC.	IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G	11/29/2001
K192916	Inova Diagnostics, Inc.	NOVA Lite DAPI dsDNA Crithidia luciliae Kit	12/11/2020
K011068	RHIGENE, INC.	RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L	04/11/2002
K990916	STELLAR BIO SYSTEMS, INC.	INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY	04/21/1999
K231616	ZEUS Scientific	ZEUS IFA(TM) nDNA Test System, ZEUS dIFine	08/31/2023