PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
FDA premarket approval P990081 · decided 2000-11-28
Approval details
- PMA number
- P990081
- Trade name
- PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 1999-12-13
- Decision date
- 2000-11-28
- Days to decision
- 351 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE PATHWAY(TM) HER 2 (CLONE CB11). THE DEVICE IS A MOUSE MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF C-ERBB-2 ANTIGEN IN SECTIONS OF FORMALIN FIXED, PARAFFIN EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN(R) TREATMENT IS BEING CONSIDERED.
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510(k) clearances by this applicant
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|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
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| VENTANA CD30 (Ber-H2) RxDx Assay (K172471) | Ventana Medical Systems, Inc. | 2018-05-08 |
| CINtec Histology (50 tests), CINtec Histology (250 tests) (DEN160019) | Ventana Medical Systems, Inc. | 2017-03-04 |
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465) | Ventana Medical Systems, Inc. | 2014-03-20 |