RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT— 510(k) K131554

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K131554 for RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT, Substantially Equivalent on 2014-01-09. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 2013-05-30
Decision date: 2014-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.