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510(k) K203599

Device
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Applicant
Immuno Concepts, N.A. , Ltd.
510(k) number
K203599
Product code
KTL
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-26
Date received
2020-12-09
Regulation
866.5100
Classification name
Anti-Dna Indirect Immunofluorescent Solid Phase
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Eric S. Hoy
Address
9825 Goethe Rd., Suite #350 Sacramento CA US 95827 95827

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KTL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus Scientific2023-08-31
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K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc.2018-04-20
K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc.2018-04-20
K011068RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LRhigene, Inc.2002-04-11
K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GImmuno Concepts, Inc.2001-11-29
K990916INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYStellar Bio Systems, Inc.1999-04-21
K930987CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)The Binding Site, Ltd.1993-08-10
K905386DISTAT ANTI-DSDNA KITShield Diagnostics, Ltd.1990-12-13
K864275ANTI-NDNA ANTIBODY TEST KITCappel Diagnostics, Inc.1986-12-15
K861978AUTOFLUOR VTechnia Diagnostics , Ltd.1986-06-10
K842707ADP NDNA IFA TESTApple Diagnostic Products1984-08-21
K834349ANTI-NATIVE DNA ANTIBODYSigma Chemical Co.1984-04-19
K834140ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYSIntl. Diagnostic Technology1984-01-20
K833984ANTINUCLEAR ANTIBODY IMMUNOLOGICALIntl. Diagnostic Technology1984-01-04