The following data is part of a premarket notification filed by Leica Biosystems Newcastle Limited with the FDA for Bond Ready-to-use (rtu) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16.
| Device ID | K171753 |
| 510k Number | K171753 |
| Device Name: | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | Leica Biosystems Newcastle Limited Balliol Business Park West, Benton Lane Newcastle Upon Tyne, GB Ne12 8ew |
| Contact | Bert Peerboom |
| Correspondent | Carol Adiletto-francis Leica Biosystems Inc. 36 Cherry Hill Drive Danvers, MA 09123 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-07-21 |