K242170
- 510(k) number
- K242170
- Device name
- K-ASSAY CRP (Ver.2)
- Applicant
- Kamiya Biomedical Company, LLC WA · US
- Product code
- DCK — C-Reactive Protein, Antigen, Antiserum, And Control
- Decision date
- 2025-04-18
- Date received
- 2024-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242170.pdf
Official FDA record: K242170
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.