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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
k163087
B. Purpose for Submission:
New device
C. Measured:
Capillary whole blood
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What is quantitative amperometric assay glucose?
Quantitative amperometric assay glucose is a method used to measure the concentration of glucose in a sample using an amperometric sensor.
Who is required to file quantitative amperometric assay glucose?
Healthcare providers and researchers who need to monitor glucose levels in a patient or subject are required to file quantitative amperometric assay glucose.
How to fill out quantitative amperometric assay glucose?
To fill out quantitative amperometric assay glucose, follow the specific instructions provided by the manufacturer of the amperometric sensor and data collection device.
What is the purpose of quantitative amperometric assay glucose?
The purpose of quantitative amperometric assay glucose is to accurately measure and monitor glucose levels in a sample for research or medical purposes.
What information must be reported on quantitative amperometric assay glucose?
The information reported on quantitative amperometric assay glucose includes the date and time of the measurement, the concentration of glucose, and any relevant notes or observations.
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