Xprecia Stride Coagulation System, Xprecia System PT Controls— 510(k) K151964

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K151964 for Xprecia Stride Coagulation System, Xprecia System PT Controls, Substantially Equivalent on 2016-09-30. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: 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

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.