Q-Linea AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Q-Linea AB - FDA 510(k) Cleared Devices
Recent clearances: ASTar BC G- Kit, ASTar BC G- Kit and ASTar Instrument
2
Total
2
Cleared
0
Denied
Q-Linea AB has 2 FDA 510(k) cleared medical devices. Based in Uppsala, SE.
Latest FDA clearance: Apr 2026. Active since 2024. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Q-Linea AB Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Q-Linea AB
2 devices