DeviceClearance

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer— 510(k) K223635

Substantially Equivalent

Sienco, Inc.

FDA 510(k) clearance K223635 for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer, Substantially Equivalent on 2023-01-04. Applicant: Sienco, Inc..

Clearance details

Applicant
Sienco, Inc.
Product code
Code JBP
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.