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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K252336
Device Name Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
Applicant
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Date Received07/28/2025
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
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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