The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Aec Detection Kit.
| Device ID | K920566 |
| 510k Number | K920566 |
| Device Name: | AEC DETECTION KIT |
| Classification | Igm, Peroxidase, Antigen, Antiserum, Control |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Contact | Phillip Miller |
| Correspondent | Phillip Miller VENTANA MEDICAL SYSTEMS, INC. 3865 N. 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 | 1992-02-07 |
| Decision Date | 1992-05-08 |