COAG-1 PT-NC TEST CARD— 510(k) K904325

Substantially Equivalent

Cardiovascular Diagnostic Services

FDA 510(k) clearance K904325 for COAG-1 PT-NC TEST CARD, Substantially Equivalent on 1991-01-25. Applicant: Cardiovascular Diagnostic Services.

Clearance details

Applicant: Cardiovascular Diagnostic Services
Product code: Code GJS
Advisory panel: Hematology
Date received: 1990-09-20
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, 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.