The following data is part of a premarket notification filed by Leica Biosystems Newcastle Ltd. with the FDA for Bond Ready-to-use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (concentrated Liquid Antibody Format)..
| Device ID | K193393 |
| 510k Number | K193393 |
| Device Name: | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane Newcastle Upon Tyne, GB Ne12 8ew |
| Contact | Matthew West |
| Correspondent | Zhijun (julie) Pan Leica Biosystems 38 Cherry Hill Drive Danvers, MA 01923 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2020-03-06 |