FDA 510(k) Applications for Medical Device Product Code: NEO (System, Test, Osteocalcin)

FDA 510(k) Applications for Medical Device Product Code "NEO"
(System, Test, Osteocalcin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K003609	OSTEOMETER BIOTECH A/S	N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000	05/16/2001
K051297	ROCHE DIAGNOSTICS CORP.	ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK	09/08/2005