The following data is part of a premarket notification filed by Biogenex Laboratories with the FDA for Biogenex Monoclonal Anti-estrogen Receptor(clone Er88).
| Device ID | K013148 |
| 510k Number | K013148 |
| Device Name: | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | BIOGENEX LABORATORIES 4600 NORRIS CANYON RD. San Ramon, CA 94583 |
| Contact | Gurvinder S Nanda |
| Correspondent | Gurvinder S Nanda BIOGENEX LABORATORIES 4600 NORRIS CANYON RD. San Ramon, CA 94583 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-20 |
| Decision Date | 2002-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850646007150 | K013148 | 000 |
| 00850646007143 | K013148 | 000 |
| 00850646007112 | K013148 | 000 |
| 00850646007105 | K013148 | 000 |
| 00850646007099 | K013148 | 000 |
| 00850646007082 | K013148 | 000 |
| 00850646007075 | K013148 | 000 |
| 00850646007068 | K013148 | 000 |