Product code NEO— Clinical Chemistry
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
- Classification name
- System, Test, Osteocalcin
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code NEO
FDA has cleared devices under product code NEO between 2001 and 2005, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2001
Top applicants under product code NEO
Recent clearances under product code NEO
Data sourced from openFDA. This site is unofficial and independent of the FDA.