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 a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-05-30 under approval 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. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K243863.
When was Opulus Lymphoma Precision approved by the FDA?
Opulus Lymphoma Precision received FDA 510(k) clearance on 2025-05-30, under approval number K243863.
What company makes Opulus Lymphoma Precision?
Opulus Lymphoma Precision is manufactured by Roche Molecular Systems, Inc..
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.