NEO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Test, Osteocalcin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK (K051297) | Roche Diagnostics Corp. | 2005-09-08 |
| N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 (K003609) | Osteometer Biotech A/S | 2001-05-16 |
Track NEO automatically
Every clearance here is in the API, with alerts when new ones post.