IGE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Solution, Formalin Ammonium Bromide
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SALINE SOLUTINE, STERILE (K950560) | Busse Hospital Disposables, Inc. | 1995-05-30 |
| CB FORMALIN (K842862) | Anatech, Ltd. | 1984-08-28 |
Track IGE automatically
Every clearance here is in the API, with alerts when new ones post.