K233242
- 510(k) number
- K233242
- Device name
- Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
- Applicant
- Siemens Healthcare Diagnostics, Inc. DE · US
- Product code
- NQD — Cardiac C-Reactive Protein, Antigen, Antiserum, And
- Decision date
- 2024-01-18
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233242.pdf
Official FDA record: K233242
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.