The following data is part of a premarket notification filed by Dako Denmark A/s with the FDA for Flex Monoclonal Rabbit Anti-human Estrogen Receptor A, Clone Epi, Rtu (dako Onmis).
| Device ID | K170028 |
| 510k Number | K170028 |
| Device Name: | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor A, Clone EPI, RTU (Dako Onmis) |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | DAKO DENMARK A/S PRODUKTIONSVEJ 42 Glostrup, DK 2600 |
| Contact | Lasse Post Moller |
| Correspondent | Lasse Post Moller DAKO DENMARK A/S PRODUKTIONSVEJ 42 Glostrup, DK 2600 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700571108147 | K170028 | 000 |