The following data is part of a premarket notification filed by Lab Vision Corp. with the FDA for Neomarkers Rabbit Monoclonal Anti-human Progesterone Receptor Antibody (clone Sp2).
| Device ID | K060462 |
| 510k Number | K060462 |
| Device Name: | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | LAB VISION CORP. 47777 WARM SPRINGS BLVD. Fremont, CA 94539 |
| Contact | Grace Chang |
| Correspondent | Grace Chang LAB VISION CORP. 47777 WARM SPRINGS BLVD. Fremont, CA 94539 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-22 |
| Decision Date | 2006-04-24 |
| Summary: | summary |