FDA Product Code
FDA Product Code DFD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5550
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K940242 | VENTANA CEA PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K924578 | PSA ANTIBODY KIT | Ventana Medical Systems, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K924629 | PAP ANTIBODY KIT | Ventana Medical Systems, Inc. | 1993-02-04 | Traditional | PDF ↗ |
Product code DFD · Class II · Immunology. Data: openFDA.