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 Alpha Antibody Clone Sp1, Model M3634.
| Device ID | K081286 |
| 510k Number | K081286 |
| Device Name: | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | DAKO NORTH AMERICA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Kelly Miller |
| Correspondent | Kelly Miller 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 | 2008-05-07 |
| Decision Date | 2009-05-08 |
| Summary: | summary |