DEN240025
- 510(k) number
- DEN240025
- Device name
- VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
- Applicant
- Ventana Medical Systems, Inc. AZ · US
- Product code
- SDP — Kappa And Lambda Immunoglobulin Light Chain In Situ
- Decision date
- 2024-12-05
- Date received
- 2024-05-29
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Hematology
Official FDA record: DEN240025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.