The following data is part of a premarket notification filed by Dako North America, Inc. with the FDA for Flex Monoclonal Rabbitt Anti-human Estrogen Receptor A, Clone Ep1, Ready-to-use (link); Flex Monoclonal Mouse Anti-human Progesterone Receptor, Clone Pgr 636, Ready-to-use (link).
| Device ID | K160922 |
| 510k Number | K160922 |
| Device Name: | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor A, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | Dako North America, Inc. 6392 Via Real Carpinteria, CA 93013 |
| Contact | Joel Weisenberger |
| Correspondent | Lasse Post Moller Dako Denmark A/S Produktionsvej 42 Glostrup, DK 2600 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-04 |
| Decision Date | 2016-05-03 |
| Summary: | summary |