ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3— 510(k) K131776

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K131776 for ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3, Substantially Equivalent on 2013-07-18. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2013-06-17
Decision date: 2013-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.