SAMPLOK LUER KIT— 510(k) K021941

Substantially Equivalent

Itl Corporation Pty, Ltd.

FDA 510(k) clearance K021941 for SAMPLOK LUER KIT, Substantially Equivalent on 2002-07-02. Applicant: Itl Corporation Pty, Ltd..

Clearance details

Applicant: Itl Corporation Pty, Ltd.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2002-06-13
Decision date: 2002-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Fyshwick, Canberra Act, AU

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.