Affinity Biosensors, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemOctober 27, 2025
K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemOctober 23, 2024
K211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemApril 2, 2024