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

Leica Biosystems Newcastle, Ltd. specializes in anatomical pathology equipment and workflow solutions. The company operates with a manufacturing facility in Richmond, US. Their mission centers on advancing cancer diagnostics and improving lives through integrated histology, immunohistochemistry, and digital pathology technologies.

The company has received 3 FDA 510(k) clearances from 3 total submissions. All submissions focused on Pathology devices. Clearances span from 2014 to 2023, with notable products including antibody panels and immunohistochemistry reagents. The company is currently inactive, with no recent FDA submissions.

Leica Biosystems Newcastle's cleared devices include primary antibodies, immunohistochemistry staining solutions, and related Pathology reagents. The company's portfolio reflects deep expertise in tissue analysis and diagnostic slide preparation. Their products support pathologists and laboratory professionals in delivering accurate diagnostic results.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.