The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Anti-keratin-hmw Primary Anti-body.
| Device ID | K941173 |
| 510k Number | K941173 |
| Device Name: | ANTI-KERATIN-HMW PRIMARY ANTI-BODY |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Contact | Stephen A Tillson |
| Correspondent | Stephen A Tillson VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson, AZ 85705 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1996-03-22 |
| Summary: | summary |