CoaguChek XS Pro System— 510(k) K180693

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K180693 for CoaguChek XS Pro System, Substantially Equivalent on 2018-04-19. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code GJS
Advisory panel: Hematology
Date received: 2018-03-16
Decision date: 2018-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, 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.