Medical Device Manufacturer · US , Santa Barbara , CA

Affinity Biosensors, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2024
2
Total
2
Cleared
0
Denied

Affinity Biosensors, LLC has 2 FDA 510(k) cleared medical devices. Based in Santa Barbara, US.

Latest FDA clearance: Oct 2025. Active since 2024. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Affinity Biosensors, LLC Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Affinity Biosensors, LLC

2 devices
1-2 of 2
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875 · SAN
Microbiology · 131d
Cleared Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K241324 · SAN
Microbiology · 166d
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