VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY
FDA premarket approval P020055 · decided 2004-08-11
Approval details
- PMA number
- P020055
- Trade name
- VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2002-12-24
- Decision date
- 2004-08-11
- Days to decision
- 596 days
- Decision code
- APPR
- Product code
- NKF
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE VENTANA MEDICAL SYSTEMS' PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY. THE DEVICE IS INDICATED AS FOLLOWS: VENTANA MEDICAL SYSTEMS' PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY IS INTENDED FOR LABORATORY USE, VIA LIGHT MICROSCOPY, FOR THE QUALITATIVE DETECTION OF KIT PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED GASTROINTESTINAL STROMAL TUMORS (GISTS) USING EITHER AN AUTOMATED IMMUNOHISTOCHEM-ISTRY STAINING SYSTEM OR A MANUAL ASSAY. IT IS INDICATED AS AN AID IN THE DIAGNOSIS OF GIST WI
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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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| CINtec Histology (K212176) | Ventana Medical Systems, Inc. | 2021-12-10 |
| 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 |