Home / 510(k) Clearances / K252336

510(k) K252336

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay by Diazyme Laboratories, Inc.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2026
Date Received
July 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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