Medical Device Manufacturer · US , Plantation , FL

Boule Medical AB - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2004

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Boule Medical AB Hematology ✕

2 devices

1-2 of 2

Cleared Feb 03, 2009

MEDONIC M SERIES

Hematology · 76d

Cleared Jan 29, 2004

MEDONIC CA620/530 HEMATOLOGY ANALYZER

Hematology · 192d