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510(k) Data Aggregation
K Number
K033137Device Name
POTENS +
Manufacturer
Date Cleared
2003-12-08
(69 days)
Product Code
Regulation Number
864.5425Why did this record match?
Applicant Name (Manufacturer) :
WADA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.
Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.
INR is used to monitor the patients receiving anticoagulation therapy.
Device Description
Semi-automated system for in vitro coagulation studies, clot based and photo-optical.
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