The following data is part of a premarket notification filed by Vision Biosystems Inc. with the FDA for Vision Biosystems Progesterone Receptor Pgr Clone 16.
| Device ID | K062615 |
| 510k Number | K062615 |
| Device Name: | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 |
| Classification | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Applicant | VISION BIOSYSTEMS INC. 1833 PORTOLA ROAD Ventura, CA 93003 |
| Contact | Ronald F Lagerquist |
| Correspondent | Ronald F Lagerquist VISION BIOSYSTEMS INC. 1833 PORTOLA ROAD Ventura, CA 93003 |
| Product Code | MXZ |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2007-01-29 |
| Summary: | summary |