510(k) K061239— EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT

Substantially Equivalent

Euroimmun Us, LLC

Clearance details

Applicant: Euroimmun Us, LLC
Product code: Code MYF
Advisory panel: Microbiology
Date received: 2006-05-03
Decision date: 2007-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boonton Township, NJ, US

Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

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.