Medical Device Manufacturer · DK , Herlev

Osteometer Biotech A/S - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1999

Recent clearances: N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000, SERUM CROSSLAPS ONE STEP ELISA

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osteometer Biotech A/S Chemistry ✕

2 devices

1-2 of 2

Cleared May 16, 2001

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

Chemistry · 175d

Cleared Jul 09, 1999

SERUM CROSSLAPS ONE STEP ELISA

Chemistry · 116d