I-STAT PROTHROMBIN TIME TEST— 510(k) K020355

Substantially Equivalent

I-Stat Corporation

FDA 510(k) clearance K020355 for I-STAT PROTHROMBIN TIME TEST, Substantially Equivalent on 2002-05-14. Applicant: I-Stat Corporation.

Clearance details

Applicant: I-Stat Corporation
Product code: Code GJS
Advisory panel: Hematology
Date received: 2002-02-04
Decision date: 2002-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Windsor, NJ, 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.