K951820

Substantially Equivalent

THROMBOPLASTIN-LI REAGENT

Applicant: Helena Laboratories
Product code: GJS
Advisory panel: Hematology
Date received: 1995-04-20
Decision date: 1995-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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.