Medical Device Manufacturer · SE , Uppsala

Q-Linea AB - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2024
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
1-2 of 2
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