K250249
- 510(k) number
- K250249
- Device name
- Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- Applicant
- Gold Standard Diagnostics, LLC CA · US
- Product code
- GMQ — Antigens, Nontreponemal, All
- Decision date
- 2025-10-10
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250249.pdf
Official FDA record: K250249
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.