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FDA 510(k)

Opulus™ Lymphoma Precision

K-Number: K243863 · 2025-05-30

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-05-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Opulus™ Lymphoma Precision is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K243863. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Opulus™ Lymphoma Precision?

Opulus™ Lymphoma Precision is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K243863.

When did Opulus™ Lymphoma Precision receive FDA 510(k) clearance?

Opulus™ Lymphoma Precision received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243863.

Who is the listed applicant for Opulus™ Lymphoma Precision?

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

What is the FDA product code for Opulus™ Lymphoma Precision?

The FDA product code for Opulus™ Lymphoma Precision is QIH.

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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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