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

FDA 510(k) Regulatory Record - Q-Linea AB Microbiology ✕

2 devices

1-2 of 2

Cleared Apr 15, 2026

ASTar BC G- Kit

Microbiology · 149d

Cleared Apr 26, 2024

ASTar BC G- Kit and ASTar Instrument

Microbiology · 686d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 08, 2026