MVD · System, Test, Her-2/Neu, Nucleic Acid Or Serum
· Class 3
Overview
| Product Code | MVD |
|---|---|
| Device Name | System, Test, Her-2/Neu, Nucleic Acid Or Serum |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P040005 | DAKOCYTOMATION HER2 FISH PHARMDX KIT | Agilent Technologies Singapore (International) Pte , Ltd. | May 3, 2005 | APPR |
| P980024 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | Dec 11, 1998 | APPR |
| P940004 | ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI | Ventana Medical Systems, Inc. | Dec 30, 1997 | APWD |
Top Applicants
- Abbott Molecular, Inc. — 1 clearance
- Agilent Technologies Singapore (International) Pte , Ltd. — 1 clearance
- Ventana Medical Systems, Inc. — 1 clearance
