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K Number
K002528

Validate with FDA (Live)

Device Name
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION
Manufacturer
SIENCO, INC.
Date Cleared
2000-08-31

(15 days)

Product Code
JBP
Regulation Number
864.7140
Type
Special
Panel
Hematology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K223635
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 864.7140 Activated whole blood clotting time tests.

(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).