K Number
K952515Device Name
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAYManufacturer
Date Cleared
1996-01-23
(237 days)
Product Code
Regulation Number
864.7060Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).