VENTANA MMR IHC Panel— 510(k) K260776
Substantially EquivalentRoche Tissue Diagnostics, Inc.
FDA 510(k) clearance K260776 for VENTANA MMR IHC Panel, Substantially Equivalent on 2026-10-23. Applicant: Roche Tissue Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Tissue Diagnostics, Inc.
- Product code
- Product code PZJ
- Device class
- Class 2
- Regulation
- 21 CFR 864.1866
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code PZJ
view all- K211181 — Idylla MSI Test
- K213348 — BOND MMR Antibody Panel
- K200129 — OncoMate MSI Dx Analysis System
- DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
Data sourced from openFDA. This site is unofficial and independent of the FDA.