VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
FDA 510(k) clearance DEN240025 · decided 2024-12-05
Clearance details
- K-number
- DEN240025
- Device name
- VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Unknown
- Date received
- 2024-05-29
- Decision date
- 2024-12-05
- Days to decision
- 190 days
- Clearance type
- Direct
- Product code
- SDP
- Device class
- 2
- Regulation number
- 864.1861
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059) | Ventana Medical Systems, Inc. | 2025-12-15 |
| HER2 Dual ISH DNA Probe Cocktail (P190031/S014) | Ventana Medical Systems, Inc. | 2025-12-15 |
| CINtec PLUS Cytology (P190024/S015) | Ventana Medical Systems, Inc. | 2025-09-04 |
| CINtec PLUS Cytology (P190024/S014) | Ventana Medical Systems, Inc. | 2025-07-31 |
| VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001) | Ventana Medical Systems, Inc. | 2025-06-20 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S025) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA PD-L1 (SP263) ASSAY (P160046/S020) | Ventana Medical Systems, Inc. | 2025-06-20 |