VITAL SCIENTIFIC PT WITH CALCIUM— 510(k) K020840

Substantially Equivalent

Vital Scientific N.V.

FDA 510(k) clearance K020840 for VITAL SCIENTIFIC PT WITH CALCIUM, Substantially Equivalent on 2002-05-15. Applicant: Vital Scientific N.V..

Clearance details

Applicant: Vital Scientific N.V.
Product code: Code GJS
Advisory panel: Hematology
Date received: 2002-03-15
Decision date: 2002-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.