NEO · Class II · 21 CFR 862.1050

FDA Product Code NEO: System, Test, Osteocalcin

Leading manufacturers include Osteometer Biotech A/S and Roche Diagnostics Corp..

2
Total
2
Cleared
144d
Avg days
2001
Since

FDA 510(k) Cleared System, Test, Osteocalcin Devices (Product Code NEO)

2 devices
1–2 of 2
Cleared Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
K051297
Roche Diagnostics Corp.
Chemistry · 113d
Cleared May 16, 2001
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
K003609
Osteometer Biotech A/S
Chemistry · 175d

About Product Code NEO - Regulatory Context