K250965
- 510(k) number
- K250965
- Device name
- Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- Applicant
- Sysmex America, Inc. IL · US
- Product code
- JPA — System, Multipurpose For In Vitro Coagulation Studie
- Decision date
- 2025-06-02
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250965.pdf
Official FDA record: K250965
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.