The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventana Red Detection Kit.
| Device ID | K932386 |
| 510k Number | K932386 |
| Device Name: | VENTANA RED DETECTION KIT |
| Classification | Igm, Peroxidase, Antigen, Antiserum, Control |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 3865 NORTH BUSINESS CENTER DR. Tucson, AZ 85705 |
| Contact | Stephen A Tilllson |
| Correspondent | Stephen A Tilllson VENTANA MEDICAL SYSTEMS, INC. 3865 NORTH BUSINESS CENTER DR. Tucson, AZ 85705 |
| Product Code | DEY |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-17 |
| Decision Date | 1993-08-09 |