The following data is part of a premarket notification filed by Leica Biosystems Newcastle Limited with the FDA for Estrogen Receptor Clone 6f11 Ready-to-use Primary Antibody For Bond, Estrogen Receptor Clone 6f11 Liquid Concentrate Primary Antibody, Novocastra.
| Device ID | K183100 |
| 510k Number | K183100 |
| Device Name: | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody For Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | Leica Biosystems Newcastle Limited Balliol Business Park West, Benton Lane Newcastle Upon Tyne, GB Ne12 8ew |
| Contact | Jeremy Allen |
| Correspondent | Zhijun (julie) Pan Leica Biosystems Inc. 38 Cherry Hill Drive Danvers, MA 01923 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-07 |
| Decision Date | 2018-12-07 |