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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Indirect Immunofluorescent Solid Phase
510(k) Number K203599
Device Name Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Applicant
Immuno Concepts, N.A. , Ltd.
9825 Goethe Rd., Suite #350
Sacramento,  CA  95827
Applicant Contact Eric S. Hoy
Correspondent
Immuno Concepts, N.A. , Ltd.
9825 Goethe Rd., Suite #350
Sacramento,  CA  95827
Correspondent Contact Eric S. Hoy
Regulation Number866.5100
Classification Product Code
KTL  
Subsequent Product Code
PIV  
Date Received12/09/2020
Decision Date 05/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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