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

Name: FDA 510(k) clearance K061239
Creator: U.S. Food and Drug Administration
Published: 2007-06-28

Substantially Equivalent

Euroimmun Us, LLC

FDA 510(k) clearance K061239 for EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT, Substantially Equivalent on 2007-06-28. Applicant: Euroimmun Us, LLC. Device class: 2.

Clearance details

Applicant: Euroimmun Us, LLC
Product code: Code MYF
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2006-05-03
Decision date: 2007-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boonton Township, NJ, US

Download summary PDF View on FDA.gov ↗

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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.