PROTHROMBIN TIME TEST CARD— 510(k) K954625

Substantially Equivalent

Cardiovascular Diagnostics, Inc.

FDA 510(k) clearance K954625 for PROTHROMBIN TIME TEST CARD, Substantially Equivalent on 1996-03-11. Applicant: Cardiovascular Diagnostics, Inc..

Clearance details

Applicant: Cardiovascular Diagnostics, Inc.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1995-09-27
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, 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.