The following data is part of a premarket notification filed by Biogenex Laboratories with the FDA for Biogenex Monoclonal Anti-progesterone Receptor.
| Device ID | K012960 |
| 510k Number | K012960 |
| Device Name: | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone 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 | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2002-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850646007136 | K012960 | 000 |
| 00850646007129 | K012960 | 000 |
| 00850646007051 | K012960 | 000 |
| 00850646007044 | K012960 | 000 |
| 00850646007037 | K012960 | 000 |
| 00850646007020 | K012960 | 000 |
| 00850646007013 | K012960 | 000 |
| 00850646007006 | K012960 | 000 |