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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY. 510(k) Number:
K151964
B. Purpose for Submission:
New device
C. Measured:
International Normalized Ratio (INR) based on Prothrombin Time
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What is international normalized ratio inr?
International Normalized Ratio (INR) is a standardized way to measure the clotting ability of the blood.
Who is required to file international normalized ratio inr?
Healthcare providers and individuals on anticoagulant therapy are required to file International Normalized Ratio (INR) tests.
How to fill out international normalized ratio inr?
To fill out an International Normalized Ratio (INR) test, a blood sample is typically taken and sent to a lab for analysis.
What is the purpose of international normalized ratio inr?
The purpose of International Normalized Ratio (INR) is to monitor and manage the effectiveness of anticoagulant therapy.
What information must be reported on international normalized ratio inr?
The International Normalized Ratio (INR) test results and relevant medical history of the individual must be reported.
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