CoaguChek XS Pro System— 510(k) K180693

Clearance details

Applicant

Roche Diagnostics

Product code

Code GJS

Device class

Class 2

Regulation

21 CFR 864.7750

Advisory panel

Hematology

Date received

2018-03-16

Decision date

2018-04-19

Decision

Substantially Equivalent

Clearance type

Special

Location

Indianapolis, IN, US

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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 →