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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 K231616
Device Name ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
Applicant
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact Mark Kopnitsky
Correspondent
Zeus Scientific
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact Mark Kopnitsky
Regulation Number866.5100
Classification Product Code
KTL  
Subsequent Product Code
PIV  
Date Received06/02/2023
Decision Date 08/31/2023
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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