PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY
FDA premarket approval P020055/S003 · decided 2012-07-24
Approval details
- PMA number
- P020055
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY
- Generic name
- Immunohistochemistry antibody assay, c-kit
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2012-06-26
- Decision date
- 2012-07-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NKF
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- ADDITION OF A SUPPLIER OF RAW MATERIALS FOR THE IVIEW DETECTION KIT, WHICH IS PART OF THE DEVICE.
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| 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 |