ACTICLOT, MODEL 824— 510(k) K052124

Substantially Equivalent

American Diagnostica, Inc.

FDA 510(k) clearance K052124 for ACTICLOT, MODEL 824, Substantially Equivalent on 2005-10-17. Applicant: American Diagnostica, Inc..

Clearance details

Applicant: American Diagnostica, Inc.
Product code: Code GJS
Advisory panel: Hematology
Date received: 2005-08-05
Decision date: 2005-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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.