Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System— 510(k) K250249
Substantially EquivalentGold Standard Diagnostics, LLC
FDA 510(k) clearance K250249 for Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System, Substantially Equivalent on 2025-10-10. Applicant: Gold Standard Diagnostics, LLC.
Clearance details
- Applicant
- Gold Standard Diagnostics, LLC
- Product code
- Code GMQ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davis, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.