INFORM HER2 Dual ISH DNA Probe Cocktail
FDA premarket approval P100027/S040 · decided 2023-11-08
Approval details
- PMA number
- P100027
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2023-10-26
- Decision date
- 2023-11-08
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- addition of an alternative supplier for dispenser component parts
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Roche Digital Pathology Dx (K242783) | Ventana Medical Systems, Inc. | 2024-12-17 |
| VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025) | Ventana Medical Systems, Inc. | 2024-12-05 |
| Roche Digital Pathology Dx (VENTANA DP 200) (K232879) | Ventana Medical Systems, Inc. | 2024-06-14 |
| 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 |