KQI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Fetal Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7455
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HBF DILUENT (K880653) | Helena Laboratories | 1988-04-21 |
| HELENA HBF QUIPLATE CONTROL (K812226) | Helena Laboratories | 1981-09-01 |
| HELENA HEMOGLOBIN F CONTROLS (K810475) | Helena Laboratories | 1981-03-26 |
| SICKLE-CELL F TEST (K791143) | Isolab, Inc. | 1979-07-17 |
Track KQI automatically
Every clearance here is in the API, with alerts when new ones post.