Medical Device Manufacturer · US , Richmond , IL

Leica Biosystems Newcastle, Ltd.

3 submissions · 3 cleared · Since 2014
3
Total
3
Cleared
0
Denied

Leica Biosystems Newcastle, Ltd. — FDA 510(k) Submissions

Leica Biosystems Newcastle, Ltd. has submitted 3 FDA 510(k) premarket notifications since 2014, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Immunohistochemistry Antibody Assay, Estrogen Receptor, Immunohistochemistry Assay, Antibody, Progesterone Receptor, Lynch Syndrome Test System . Use the specialty filter in the sidebar to narrow results.

3 devices
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All3 Pathology 3