Leica Biosystems Newcastle, Limited is one of 439 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.
Leica Biosystems Newcastle, Limited - FDA 510(k) Cleared Devices
Recent clearances: Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra, BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody, BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
3
Total
3
Cleared
0
Denied
Leica Biosystems Newcastle, Limited has 3 FDA 510(k) cleared medical devices. Based in Newcastle Upon Tyne, GB.
Historical record: 3 cleared submissions from 2017 to 2018. Primary specialty: Pathology.
Browse the FDA 510(k) cleared devices submitted by Leica Biosystems Newcastle, Limited Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Leica Biosystems, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Leica Biosystems Newcastle, Limited
3 devices
Cleared
Dec 07, 2018
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen...
Pathology
30d
Cleared
Dec 07, 2018
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) ,...
Pathology
30d
Cleared
Jul 21, 2017
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16),...
Pathology
39d