Data / Medical devices / United Kingdom / Leica Biosystems Newcastle Ltd
Leica Biosystems Newcastle Ltd: FDA-registered device maker in Newcastle Upon Tyne, United Kingdom, 6 510(k) clearances and 1 PMA approval
Leica Biosystems Newcastle Ltd is registered with the FDA (registration 3004859032) in Newcastle Upon Tyne, United Kingdom. It lists 8 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated February 21, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004859032
- Address
- Balliol Business Park West Benton Lane, Newcastle Upon Tyne, United Kingdom, NE12 8EW
- Owner or operator
- Leica Biosystems, division of Leica Microsystems, Inc. (10054155)
- Roles
- Manufacturer
- First device listed
- February 23, 2017
- Registered through
- 2026
- Brand names listed
- 0.1ml NCL-ER-6F11 Class II, 0.2 M Hydrochloric acid, 0.4x SSC / 0.3% Igepal (Wash Buffer I), 0.5ml NCL-L-ALK, 0.5ml NCL-L-CD19-163, 0.5ml NCL-L-CD1a-235, 0.5ml NCL-L-CD4-368, 01P001B495 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Antibody Assay, Estrogen Receptor | MYA | 2 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Assay, Antibody, Progesterone Receptor | MXZ | 2 | Manufacturer | accessdata.fda.gov |
| Immunohistochemistry Reagents And Kits | NJT | 1 | Manufacturer | accessdata.fda.gov |
| Lynch Syndrome Test System | PZJ | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Slide Stainer, Automated | KPA | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Her-2/Neu, Ihc | MVC | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 21, 2023 | K213348 | BOND MMR Antibody Panel | PZJ | Substantially Equivalent | Leica Biosystems Newcastle, Ltd. | accessdata.fda.gov |
| March 6, 2020 | K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | MXZ | Substantially Equivalent | Leica Biosystems Newcastle, Ltd. | accessdata.fda.gov |
| December 7, 2018 | K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | MXZ | Substantially Equivalent | Leica Biosystems Newcastle, Limited | accessdata.fda.gov |
| December 7, 2018 | K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | MYA | Substantially Equivalent | Leica Biosystems Newcastle, Limited | accessdata.fda.gov |
| January 29, 2007 | K062615 | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 | MXZ | Substantially Equivalent | Vision Biosystems, Inc. | accessdata.fda.gov |
| May 25, 2006 | K060227 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | MYA | Substantially Equivalent | Vision Biosystems, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 18, 2012 | P090015 | BOND ORACLE HER2 IHC SYSTEM | MVC | 14 | June 4, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 31, 2013 | 66030 | Class II | Terminated | Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bon | The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide. | accessdata.fda.gov |
Compare with other makers
- All makers of Slide Stainer, Automated
- All makers of Reagents, Specific, Analyte
- All makers of System, Test, Her-2/Neu, Ihc
- All makers of Immunohistochemistry Reagents And Kits
- All makers of General Purpose Reagent
- All makers of Immunohistochemistry Antibody Assay, Estrogen Receptor
Updated June 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.