IGC
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Formalin-Saline
- 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 |
|---|---|---|
| INCSTAR HSZ I/II IGG ELISA ASSAY (K955363) | Incstar Corp. | 1996-07-24 |
| INCSTAR HSV I/II IGG FAST ELISA ASSAY (K955362) | Incstar Corp. | 1996-07-24 |
Track IGC automatically
Every clearance here is in the API, with alerts when new ones post.