# Leica Biosystems Newcastle, Ltd.

- Location (FDA's records): Newcastle Upon Tyne, GB
- FDA decisions: 6 (2014–2023): 6 510(k) clearances
- Names in FDA's records: Leica Biosystems Newcastle, Ltd. (3); Leica Biosystems Newcastle, Limited (3)
- Product codes: MXZ (3), MYA (2), PZJ (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ventana Medical Systems, Inc.: 1 (https://510kreport.com/company/ventana-medical-systems)
- Vision Biosystems, Inc.: 1 (https://510kreport.com/company/vision-biosystems)

## Its most-cited devices
- K171753: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (2017), cited by 1

## Recent decisions
- K213348: BOND MMR Antibody Panel (Feb 21, 2023)
- K193393: BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). (Mar 6, 2020)
- K183100: Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra (Dec 7, 2018)
- K183102: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody (Dec 7, 2018)
- K171753: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Jul 21, 2017)
- K122556: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) (May 19, 2014)

Source page: https://510kreport.com/company/leica-biosystems-newcastle
