K253573
- 510(k) number
- K253573
- Device name
- ASTar BC G- Kit
- Applicant
- Q-Linea AB SE
- Product code
- SAN — Automated Antimicrobial Susceptibility Test System F
- Decision date
- 2026-04-15
- Date received
- 2025-11-17
- 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: K253573.pdf
Official FDA record: K253573
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.