Clearance Summary
ASTar BC G- Kit received FDA 510(k) clearance under submission number K253573, sponsored by Q-Linea AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-04-15.
- Submission: K253573
- Applicant / Sponsor: Q-Linea AB
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1650
- Decision date: 2026-04-15
Classification & Regulation
This clearance is catalogued under FDA product code SAN and 21 CFR 866.1650, within the Microbiology review panel as a Class II device.