RANDOX IMMUNOASSAY CONTROL— 510(k) K040379

Clearance details

Applicant

Randox Laboratories, Ltd.

Product code

Code JJY

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2004-02-17

Decision date

2004-06-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Crumlin, GB

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• Z-1105-2019 — Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insertClass III·Terminated·Randox Laboratories Ltd.·20190207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040379.