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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lynch Syndrome Test System
510(k) Number K260776
Device Name VENTANA MMR IHC Panel
Applicant
Roche Tissue Diagnostics, Inc.
1910 E. Innovation Park Dr.
Tucson,  AZ  85755
Applicant Contact Mrunalini Deokar
Correspondent
Roche Tissue Diagnostics, Inc.
1910 E. Innovation Park Dr.
Tucson,  AZ  85755
Correspondent Contact Mrunalini Deokar
Regulation Number864.1866
Classification Product Code
PZJ  
Date Received03/10/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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