The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Chemmate Kappa.
| Device ID | K973391 |
| 510k Number | K973391 |
| Device Name: | CHEMMATE KAPPA |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Contact | Kathleen Windall |
| Correspondent | Kathleen Windall VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Product Code | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-10-03 |
| Summary: | summary |