RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3— 510(k) K121588

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K121588 for RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3, Substantially Equivalent on 2012-06-20. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2012-05-31
Decision date: 2012-06-20
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.