Randox Rx Daytona

• • Ongoing Z-0198-2024 FDA Class II ·initiated 6 Sep 2023

  RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

510(k) Number

K024014 ↗

FDA Product Code

CGA

FDA applicant

Randox Laboratories, Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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