The following data is part of a premarket notification filed by Vision Biosystems Inc. with the FDA for Vision Biosystems Estrogen Receptor Clone 6f11 (er 6f11).
| Device ID | K060227 |
| 510k Number | K060227 |
| Device Name: | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | VISION BIOSYSTEMS INC. 700 LONGWATER DRIVE Norwell, MA 02061 |
| Contact | Ron Lagerquist |
| Correspondent | Ron Lagerquist VISION BIOSYSTEMS INC. 700 LONGWATER DRIVE Norwell, MA 02061 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-30 |
| Decision Date | 2006-05-25 |
| Summary: | summary |