The following data is part of a premarket notification filed by Dako North America, Inc. with the FDA for Monoclonal Mouse Anti-human Progesterone Receptor, Clone Pgr 636, Ready-to-use (link).
| Device ID | K130861 |
| 510k Number | K130861 |
| Device Name: | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | DAKO NORTH AMERICA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Jennifer M Chambers |
| Correspondent | Jennifer M Chambers DAKO NORTH AMERICA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-28 |
| Decision Date | 2013-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700571101759 | K130861 | 000 |