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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K223635
Device Name Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
Applicant
Sienco, Inc.
5721 Arapahoe Ave., Unit A1-A
Boulder,  CO  80303
Applicant Contact Jennifer Aiken
Correspondent
Sienco, Inc.
5721 Arapahoe Ave., Unit A1-A
Boulder,  CO  80303
Correspondent Contact Jennifer Aiken
Regulation Number864.7140
Classification Product Code
JBP  
Subsequent Product Code
JPA  
Date Received12/05/2022
Decision Date 01/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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