DIMENSION CLINICAL CHEMISTRY SYSTEM— 510(k) K112999

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K112999 for DIMENSION CLINICAL CHEMISTRY SYSTEM, Substantially Equivalent on 2011-11-22. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 2011-10-07
Decision date: 2011-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.