Randox Immunoassay Control

by Randox Laboratories Limited 510(k)

Active United States

510(k) K040379

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK040379	Date16 Jun 2004Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

- Terminated Z-1105-2019 FDA Class III initiated 7 Feb 2019
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

Specification

510(k)

510(k) Number: K040379
FDA Product Code: JJY
FDA applicant: Randox Laboratories, Ltd.

Device Class: Class I
Regulation: 21 CFR Part 862.1660
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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