LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG— 510(k) K081687

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K081687 for LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG, Substantially Equivalent on 2008-11-10. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code MYF
Advisory panel: Microbiology
Date received: 2008-06-17
Decision date: 2008-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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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.