LGL
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Bart'S, Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- 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 |
|---|---|---|
| ALPHA-THAL SCREEN TM CONTROL (K810976) | Isolab, Inc. | 1981-05-29 |
| ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT (K801771) | Isolab, Inc. | 1981-01-16 |
Track LGL automatically
Every clearance here is in the API, with alerts when new ones post.