K211815
- 510(k) number
- K211815
- Device name
- LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
- Applicant
- Affinity Biosensors CA · US
- Product code
- SAN — Automated Antimicrobial Susceptibility Test System F
- Decision date
- 2024-04-02
- Date received
- 2021-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K211815.pdf
Official FDA record: K211815
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.