Opulus Lymphoma Precision— 510(k) K243863
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K243863 for Opulus Lymphoma Precision, Substantially Equivalent on 2025-05-30. Applicant: Roche Molecular Systems, Inc..
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.