Elecsys HSV-2 IgG (08948887160)— 510(k) K220924

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K220924 for Elecsys HSV-2 IgG (08948887160), Substantially Equivalent on 2022-10-12. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code MYF
Advisory panel: Microbiology
Date received: 2022-03-31
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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.