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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k183549 B. Purpose for Submission: New device C. Measured: Sodium, potassium,

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Who needs non-in vitro diagnostic device?

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Anyone who needs to perform a diagnostic test that is not related to in vitro diagnostics may need a non-in vitro diagnostic device.

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This could include healthcare professionals, researchers, or individuals seeking to monitor their own health outside of a clinical setting.

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What is non-in vitro diagnostic device?

Non-in vitro diagnostic devices are medical devices that are not intended for use in testing samples outside of the body.

Who is required to file non-in vitro diagnostic device?

Manufacturers, distributors, and importers of non-in vitro diagnostic devices are required to file.

How to fill out non-in vitro diagnostic device?

Non-in vitro diagnostic devices can be filled out by providing information about the device, manufacturer, intended use, and any risks associated with its use.

What is the purpose of non-in vitro diagnostic device?

The purpose of non-in vitro diagnostic devices is to provide information or tools for diagnosing medical conditions or monitoring health.

What information must be reported on non-in vitro diagnostic device?

Information such as device name, intended use, manufacturer information, risk classification, and any adverse events must be reported.

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