Device Listing 1119103154
Listing Summary#
- Listing key
- 1119103154
- Premarket submission
- K250249
- Device
- Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- Applicant
- Gold Standard Diagnostics, LLC
- Product code
- GMQ
- Decision date
- 2025-10-10