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The Tracker / October 2026 / K260776

510(k) cleared

VENTANA MMR IHC Panel

Roche Tissue Diagnostics, Inc. · Oct 23, 2026 · K260776

FDA cleared the VENTANA MMR IHC Panel from Roche Tissue Diagnostics, Inc. on Oct 23, 2026 under K260776, a traditional 510(k). The device falls under product code PZJ, Lynch Syndrome Test System, regulated at 21 CFR 864.1866 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Mar 10, 2026. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Roche Tissue Diagnostics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260776?

K260776 is the FDA 510(k) for VENTANA MMR IHC Panel, submitted by Roche Tissue Diagnostics, Inc.. FDA's decision date was Oct 23, 2026, under product code PZJ (Lynch Syndrome Test System).

Who makes the VENTANA MMR IHC Panel?

Roche Tissue Diagnostics, Inc., based in Tucson, AZ, is the applicant of record for K260776.

How long did the K260776 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on Oct 23, 2026, 227 days later.

← All decisions in October 2026