510(k) DEN240025
- Device
- VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
- Applicant
- Ventana Medical Systems, Inc.
- 510(k) number
- DEN240025
- Product code
- SDP
- Decision
- Unknown (DENG)
- Decision date
- 2024-12-05
- Date received
- 2024-05-29
- Regulation
- 864.1861
- Classification name
- Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Patricia Wade
- Address
- 1910 E. Innovation Park Dr. Tucson AZ US 85755 85755
FDA Registration Numbers#
- 2028492
Source Documents#
510(k) summary PDF not indicated by FDA