The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Monoclonal Mouse Anti-human Estrogen Receptor.
| Device ID | K993957 |
| 510k Number | K993957 |
| Device Name: | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | DAKO CORP. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Gretchen M Murray |
| Correspondent | Gretchen M Murray DAKO CORP. 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 | 1999-11-22 |
| Decision Date | 2000-03-03 |
| Summary: | summary |