510(k) clearance
VENTANA MMR IHC Panel
- 510(k) number
- K260776
- Applicant
- Roche Tissue Diagnostics, Inc.
- Decision date
- Oct 23, 2026
- Date received
- Mar 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PZJ
- Device type
- Lynch Syndrome Test System
- Device class
- Class II
- Regulation
- 21 CFR 864.1866
- Advisory committee
- Immunology
- Statement or summary
- Summary
- Third party
- N
- Location
- Tucson, AZ, US