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ConcizuTrace™ ELISA

DEN240035 Class II Direct
Decision Date
2025-05-22
Sponsor / Applicant
Randox Laboratories, Ltd.

Technical Specification

510(k) Submission ID DEN240035
Product Code SES
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.7298
Decision Date 2025-05-22
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ConcizuTrace™ ELISA received FDA 510(k) clearance under submission number DEN240035, sponsored by Randox Laboratories, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2025-05-22.

Classification & Regulation

This clearance is catalogued under FDA product code SES and 21 CFR 864.7298, within the Hematology review panel as a Class II device.