K230675
- 510(k) number
- K230675
- Device name
- VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- Applicant
- Specific Diagnostics, LLC CA · US
- Product code
- SAN — Automated Antimicrobial Susceptibility Test System F
- Decision date
- 2024-06-20
- Date received
- 2023-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K230675.pdf
Official FDA record: K230675
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.