KTO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reagent, Immunoassay, Igg
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5530
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 1995: 1 · 2001: 2
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 |
|---|---|---|
| RAICHEM(TM) SPIA(TM) IGG REAGENTS (K894416) | Reagents Applications, Inc. | 1989-08-01 |
| KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT (K854483) | Kallestad Laboratories, Inc. | 1985-12-11 |
Track KTO automatically
Every clearance here is in the API, with alerts when new ones post.