ConcizuTrace™ ELISA

by Randox Laboratories Limited 510(k)

Active United States

510(k) DEN240035

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA De NovoDENG De Novo granted · Direct	NumberDEN240035	Date22 May 2025Decided	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

510(k)

510(k) Number: DEN240035
FDA Product Code: SES
FDA applicant: Randox Laboratories, Ltd.

Device Class: Class II
Regulation: 21 CFR Part 864.7298
Advisory Committee: Hematology
FDA Decision: DENG De Novo granted

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