K251875
- 510(k) number
- K251875
- Device name
- LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- Applicant
- Affinity Biosensors, LLC CA · US
- Product code
- SAN — Automated Antimicrobial Susceptibility Test System F
- Decision date
- 2025-10-27
- Date received
- 2025-06-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K251875.pdf
Official FDA record: K251875
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.