KSI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lectins And Protectins
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9550
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2025: 700
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LECTIN-A (K820368) | American Dade | 1982-04-14 |
| LECTIN H (K813413) | American Dade | 1982-03-04 |
| POLY-LEC SYSTEM (K792582) | Gamma Biologicals, Inc. | 1980-01-16 |
| GAMMA ARACHIS HYPOGEA LECTIN (K792583) | Gamma Biologicals, Inc. | 1980-01-16 |
Track KSI automatically
Every clearance here is in the API, with alerts when new ones post.