Leica Biosystems Newcastle Ltd.
NEWCASTLE UPON TYNE Newcastle upon Tyne, GB
LEICA BIOSYSTEMS NEWCASTLE LTD appears in FDA device records in NEWCASTLE UPON TYNE Newcastle upon Tyne, GB. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Leica Biosystems Newcastle Ltd. between 2014 and 2023. The busiest year on record is 2018, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213348 | BOND MMR Antibody Panel | PZJ | Substantially Equivalent | |
| 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 | |
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | MXZ | Substantially Equivalent | |
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | MYA | Substantially Equivalent | |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | MXZ | Substantially Equivalent | |
| K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | MYA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004859032 | 3004859032 | LEICA BIOSYSTEMS NEWCASTLE LTD | BALLIOL BUSINESS PARK WEST, NEWCASTLE UPON TYNE NE12 8EW GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PPMGeneral Purpose Reagent
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor
- NJTImmunohistochemistry Reagents And Kits
- PZJLynch Syndrome Test System
- MVUReagents, Specific, Analyte
- KPASlide Stainer, Automated
- MVCSystem, Test, Her-2/Neu, Ihc
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0717-2014 | 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; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. This detection system is for in vitro diagnostic use. Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system. The clinical interpretation of any staining or its absence should be complemented by morphological studies. Proper controls should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The Bond Polymer Refine Red Detection must be used with laboratory best practice in the use of tissue controls. For assurance, laboratories should stain each patient sample in conjunction with positive, negative and other tissue specific controls as needed. | 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. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Leica Biosystems Newcastle Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain