K253188
- 510(k) number
- K253188
- Device name
- CoaguChek XS Plus System
- Applicant
- Roche Diagnostics IN · US
- Product code
- GJS — Test, Time, Prothrombin
- Decision date
- 2025-10-24
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253188.pdf
Official FDA record: K253188
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.