MULTIPLE (IZON DNA BLOOD COLLECTION KIT)— 510(k) K010328

Substantially Equivalent

Izon Business Products, Inc.

FDA 510(k) clearance K010328 for MULTIPLE (IZON DNA BLOOD COLLECTION KIT), Substantially Equivalent on 2001-04-09. Applicant: Izon Business Products, Inc..

Clearance details

Applicant: Izon Business Products, Inc.
Product code: Code PJE
Advisory panel: Clinical Chemistry
Date received: 2001-02-02
Decision date: 2001-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Nyack, NY, US

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Adverse events under product code PJE

product code PJE

Malfunction: 540
Total: 540

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.