The following data is part of a premarket notification filed by Leica Biosystems Newcastle Ltd with the FDA for Vision Biosystems Estrogen Receptor Clone 6f11 (er 6f11).
| Device ID | K122556 |
| 510k Number | K122556 |
| Device Name: | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | LEICA BIOSYSTEMS NEWCASTLE LTD 5205 Route 12 Richmond, IL 60071 |
| Contact | Barbara-ann Conway-mayers |
| Correspondent | Barbara-ann Conway-mayers LEICA BIOSYSTEMS NEWCASTLE LTD 5205 Route 12 Richmond, IL 60071 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2014-05-19 |
| Summary: | summary |