510(k) K854376— HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS

Substantially Equivalent

Hemotec, Inc.

Clearance details

Applicant: Hemotec, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1985-10-30
Decision date: 1985-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, 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.