The following data is part of a premarket notification filed by Dako North America, Inc. with the FDA for Monoclonal Rabbit Anti-human Estrogen Receptor (er) A, Clone Epi.
| Device ID | K120663 |
| 510k Number | K120663 |
| Device Name: | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | DAKO NORTH AMERICA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Xiaolei Xu |
| Correspondent | Xiaolei Xu DAKO NORTH AMERICA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-05 |
| Decision Date | 2013-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700571106907 | K120663 | 000 |