DFD — Kappa, Peroxidase, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DFD
- Device Class
- Class II
- Regulation Number
- 866.5550
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K940242 | ventana medical systems | VENTANA CEA PRIMARY ANTIBODY | December 23, 1996 |
| K924578 | ventana medical systems | PSA ANTIBODY KIT | February 5, 1993 |
| K924629 | ventana medical systems | PAP ANTIBODY KIT | February 4, 1993 |