Source document or public record
FDA 510(k) K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
FDA 510(k) index record K223635. Device: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer. Applicant as listed: Sienco, Inc.. Decision date: 2023-01-04.
Source
"device_name": "Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K223635.
Device name: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer. Applicant as listed: Sienco, Inc..
Decision date: 2023-01-04. Decision wording: Substantially Equivalent.
Product code: JBP. Regulation: 21 CFR 864.7140. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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