INFORM HER2 Dual ISH DNA Probe Cocktail
FDA premarket approval P100027/S026 · decided 2017-03-13
Approval details
- PMA number
- P100027
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INFORM HER2 Dual ISH DNA Probe Cocktail
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Ventana Medical Systems, Inc.
- Date received
- 2016-11-15
- Decision date
- 2017-03-13
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for software modification in the BenchMark XT from NexES to VSS 12.5 and associated hardware changes.
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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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| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
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| 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 |