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K Number
K010599

Validate with FDA (Live)

Device Name
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
Manufacturer
INTERNATIONAL TECHNIDYNE CORP.
Date Cleared
2001-07-02

(124 days)

Product Code
GJS
Regulation Number
864.7750
Type
Special
Panel
Hematology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K020831,K021190
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).