The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventana Cd30 (ber-h2) Rxdx Assay.
| Device ID | K172471 |
| 510k Number | K172471 |
| Device Name: | VENTANA CD30 (Ber-H2) RxDx Assay |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | Ventana Medical Systems, Inc. 1910 E Innovation Park Dr Tuscon, AZ 87555 |
| Contact | Jeffrey Catania |
| Correspondent | Jeffrey Catania Ventana Medical Systems, Inc. 1910 E Innovation Park Dr Tuscon, AZ 87555 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-15 |
| Decision Date | 2018-05-08 |
| Summary: | summary |