ASTar BC G- Kit— 510(k) K253573
Substantially EquivalentQ-Linea AB
FDA 510(k) clearance K253573 for ASTar BC G- Kit, Substantially Equivalent on 2026-04-15. Applicant: Q-Linea AB. Device class: 2.
Summary
Q-Linea AB's ASTar BC G- Kit is filed under product code SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples). The record doesn't describe the kit beyond its name and that code name.
Class II, 21 CFR 866.1650. Microbiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Q-Linea filed from Uppsala, Sweden. The record shows 149 calendar days from receipt to decision (November 17, 2025 to April 15, 2026).
Clearance details
- Applicant
- Q-Linea AB
- Product code
- Product code SAN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1650
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
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More clearances from Q-Linea AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.