The following data is part of a premarket notification filed by Dakocytomation California, Inc. with the FDA for Dakocytomation Er/pr Pharmdx Kit.
| Device ID | K042884 |
| 510k Number | K042884 |
| Device Name: | DAKOCYTOMATION ER/PR PHARMDX KIT |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL Carpinteria, CA 93013 |
| Contact | Tiffany D Almeroth |
| Correspondent | Tiffany D Almeroth DAKOCYTOMATION CALIFORNIA, 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 | 2004-10-19 |
| Decision Date | 2005-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05700571105146 | K042884 | 000 |
| 05700571104897 | K042884 | 000 |
| 05700571104354 | K042884 | 000 |