510(k) clearance
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)
- 510(k) number
- K260909
- Applicant
- Sienco, Inc.
- Decision date
- Oct 27, 2026
- Date received
- Mar 19, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- JPA
- Device type
- System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II
- Regulation
- 21 CFR 864.5425
- Advisory committee
- Hematology
- Statement or summary
- Summary
- Third party
- N
- Location
- Boulder, CO, US