| Record ID | P940004 |
|---|---|
| Device Name | ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI |
| Applicant | Ventana Medical Systems, Inc. |
| Product Code | MVD · Pathology |
| Decision Date | Dec 30, 1997 |
| Decision | APWD |
| Device Class | Class 3 |
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