COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING— 510(k) K030845

Name: FDA 510(k) clearance K030845
Creator: U.S. Food and Drug Administration
Published: 2003-05-22

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K030845 for COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING, Substantially Equivalent on 2003-05-22. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 2003-03-17
Decision date: 2003-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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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.