510(k) K083159— BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

Substantially Equivalent

Siemens Healthcare Diagnostics

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code JPA
Advisory panel: Hematology
Date received: 2008-10-27
Decision date: 2009-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, 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.