K221688
- 510(k) number
- K221688
- Device name
- ASTar BC G- Kit and ASTar Instrument
- Applicant
- Q-Linea AB SE
- Product code
- SAN — Automated Antimicrobial Susceptibility Test System F
- Decision date
- 2024-04-26
- Date received
- 2022-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K221688.pdf
Official FDA record: K221688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.