K853986

Substantially Equivalent

THROMBOPLASTIN-R REAGENT

Applicant: American Dade
Product code: JPA
Advisory panel: Hematology
Date received: 1985-09-27
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.