NEO — System, Test, Osteocalcin Class II
FDA Device Classification
Classification Details
- Product Code
- NEO
- Device Class
- Class II
- Regulation Number
- 862.1050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K051297 | roche diagnostics | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCH | September 8, 2005 |
| K003609 | osteometer biotech | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | May 16, 2001 |