K232624
- 510(k) number
- K232624
- Device name
- CardioPhase® hsCRP
- Applicant
- Siemens Healthcare Diagnostic Products GmbH DE
- Product code
- DCN — System, Test, C-Reactive Protein
- Decision date
- 2023-11-27
- Date received
- 2023-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232624.pdf
Official FDA record: K232624
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.