Company ยท GB
Leica Biosystems Newcastle, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2023 | K213348 | BOND MMR Antibody Panel Leica Biosystems Newcastle, Ltd., GB | PZJ |
| Mar 6, 2020 | K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Leica Biosystems Newcastle, Ltd., GB | MXZ |
| Dec 7, 2018 | K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal An Leica Biosystems Newcastle, Limited, GB | MXZ |
| Dec 7, 2018 | K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Pri Leica Biosystems Newcastle, Limited, GB | MYA |
| Jul 21, 2017 | K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progest Leica Biosystems Newcastle, Limited, GB | MXZ |
| May 19, 2014 | K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) Leica Biosystems Newcastle, Ltd. | MYA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2014 | Leica Biosystems Newcastle Ltd. 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.Leic Terminated |
NJT | None listed |