K253658
- 510(k) number
- K253658
- Device name
- STA Satellite Max®
- Applicant
- Diagnostica Stago, Inc. NJ · US
- Product code
- JPA — System, Multipurpose For In Vitro Coagulation Studie
- Decision date
- 2026-04-27
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253658.pdf
Official FDA record: K253658
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.