K862669

Substantially Equivalent

ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

Applicant: U. S. Diagnostics, Inc.
Product code: GFD
Advisory panel: General, Plastic Surgery
Date received: 1986-07-14
Decision date: 1986-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

Adverse events under product code GFD

product code GFD

Injury: 544
Malfunction: 3,575
Other: 1
Total: 4,120

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.