K010328

Substantially Equivalent

MULTIPLE (IZON DNA BLOOD COLLECTION KIT)

Applicant: Izon Business Products, Inc.
Product 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

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.