The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Monoclonal Mouse Anti-human Progesterone Receptor, Clone Pgr 636, Antibody For Immunoenzymatic Staining.
| Device ID | K020023 |
| 510k Number | K020023 |
| Device Name: | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone 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 | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-03 |
| Decision Date | 2002-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700571102305 | K020023 | 000 |
| 05700571102299 | K020023 | 000 |