K033234

Substantially Equivalent

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

Applicant: Diagnostic Products Corp.
Product code: DHA
Advisory panel: Clinical Chemistry
Date received: 2003-10-06
Decision date: 2003-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.