Affinity Biosensors
Affinity Biosensors appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 27, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | October 27, 2025 |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | October 23, 2024 |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | April 2, 2024 |