K260160
- 510(k) number
- K260160
- Device name
- VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- Applicant
- bioMerieux, Inc. MO · US
- Product code
- SAN — Automated Antimicrobial Susceptibility Test System F
- Decision date
- 2026-07-08
- Date received
- 2026-01-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260160.pdf
Official FDA record: K260160
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.