MVC · System, Test, Her-2/Neu, Ihc
· Class 3
Overview
| Product Code | MVC |
|---|---|
| Device Name | System, Test, Her-2/Neu, Ihc |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P090015 | BOND ORACLE HER2 IHC SYSTEM | Leica Biosystems | Apr 18, 2012 | APPR |
| P040030 | INSITE HER-2/NEU KIT | Biogenex Laboratories, Inc. | Dec 22, 2004 | APWD |
| P990081 | PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Nov 28, 2000 | APPR |
| P980018 | DAKO HERCEPTEST | Agilent Technologies Singapore (International) Pte , Ltd. | Sep 25, 1998 | APPR |
Top Applicants
- Agilent Technologies Singapore (International) Pte , Ltd. — 1 clearance
- Biogenex Laboratories, Inc. — 1 clearance
- Leica Biosystems — 1 clearance
- Ventana Medical Systems, Inc. — 1 clearance
