K151964

Substantially Equivalent

Xprecia Stride Coagulation System, Xprecia System PT Controls

Applicant: Siemens Healthcare Diagnostics
Product code: GJS
Advisory panel: Hematology
Date received: 2015-07-16
Decision date: 2016-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norowood, MA, US

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.