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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Blood Test For Amyloid Pathology Assessment
510(k) Number K253240
Device Name PrecivityAD2 Test
Applicant
C2N Diagnostics, LLC
4340 Duncan Ave.
St. Louis,  MO  63110
Applicant Contact Ilana Fogelman
Correspondent
C2N Diagnostics, LLC
4340 Duncan Ave.
St. Louis,  MO  63110
Correspondent Contact Ilana Fogelman
Classification Product Code
SET  
Date Received09/29/2025
Decision Date 08/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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