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K Number
K961938
Device Name
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
Manufacturer
NOVA BIOMEDICAL CORP.
Date Cleared
1996-06-28

(39 days)

Product Code
GJS,CEM,CGA,JPK,KHP
Regulation Number
864.7750
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).