510(k) K131334— HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
Substantially EquivalentGold Standard Diagnostics
Clearance details
- Applicant
- Gold Standard Diagnostics
- Product code
- Code MXJ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davis, CA, US
Adverse events under product code MXJ
product code MXJ- Injury
- 139
- Total
- 139
Source: openFDA MAUDE database, through . 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.