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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
510(k) Number K253528
Device Name Atellica IM CA 19-9 II
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact Kelly Maher
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact Kelly Maher
Regulation Number866.6010
Classification Product Code
NIG  
Subsequent Product Code
JJX  
Date Received11/13/2025
Decision Date 08/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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