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FDA 510(k)

VENTANA MMR IHC Panel

K-Number: K260776 · 2026-10-23

ApplicantRoche Tissue Diagnostics, Inc.
Decision Date2026-10-23
Product CodePZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VENTANA MMR IHC Panel is the device name listed in this FDA 510(k) record. The listed applicant is Roche Tissue Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K260776. The device is classified under product code PZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA MMR IHC Panel?

VENTANA MMR IHC Panel is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is Roche Tissue Diagnostics, Inc.. The 510(k) number is K260776.

When did VENTANA MMR IHC Panel receive FDA 510(k) clearance?

VENTANA MMR IHC Panel received FDA 510(k) clearance on 2026-10-23, under 510(k) number K260776.

Who is the listed applicant for VENTANA MMR IHC Panel?

The FDA 510(k) record lists Roche Tissue Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTANA MMR IHC Panel?

The FDA product code for VENTANA MMR IHC Panel is PZJ.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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