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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k043443 B. Purpose for Submission: Clearance of new device C. Measured: Human Chorionic Gonadotrophin

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What is 510k number - accessdata?

The 510(k) number is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).

Who is required to file 510k number - accessdata?

Manufacturers of medical devices are required to file a 510(k) submission to FDA.

How to fill out 510k number - accessdata?

To fill out a 510(k) submission, manufacturers must include information about the device, its similarities to a predicate device, and any differences that may affect safety or effectiveness.

What is the purpose of 510k number - accessdata?

The purpose of a 510(k) submission is to demonstrate that a medical device is as safe and effective as a legally marketed device (predicate device) and therefore can be marketed in the US.

What information must be reported on 510k number - accessdata?

The 510(k) submission must include information about the device, performance data, labeling, and any clinical studies conducted.

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