Medical Device Manufacturer · US , Richmond , IL

Leica Biosystems Newcastle, Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2014

Official Website

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Leica Biosystems Newcastle, Ltd. Pathology ✕

3 devices

1-3 of 3

Cleared Feb 21, 2023

BOND MMR Antibody Panel

Pathology · 501d

Cleared Mar 06, 2020

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra...

Pathology · 91d

Cleared May 19, 2014

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)

Pathology · 635d