ZEUS ELISA HSV GG-2 IGG TEST SYSTEM— 510(k) K103603

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K103603 for ZEUS ELISA HSV GG-2 IGG TEST SYSTEM, Substantially Equivalent on 2011-05-20. Applicant: Zeus Scientific, Inc..

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code MYF
Advisory panel: Microbiology
Date received: 2010-12-08
Decision date: 2011-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, 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.