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Page 1of 3 Baird Laboratories Premarket Notification Section 510 (k) Liquid Assayed Multihull Summary of Safety and Effectiveness Liquid Assayed Multihull 1.0 / / 3 7 7 Submitter Blood Laboratories

How to fill out 510 k page 1

How to fill out 510 k page 1

1. Review the instructions and guidance provided by FDA for filling out the 510(k) page 1.
2. Start by providing the required general information such as the name and address of the submitter, including contact person details.
3. Include the applicant's name, address, and contact information.
4. Clearly identify the device by providing its common or trade name, intended use, and any applicable product codes.
5. Specify whether the submission is for a new product, a modification, or a resubmission.
6. If applicable, include the previous 510(k) number(s) and indicate the reason for the current submission.
7. Attach relevant supporting documents such as labeling, summary reports, and test data to support the application.
8. Ensure that all necessary sections and fields are completed accurately and in accordance with the provided instructions.
9. Review the completed page 1 thoroughly before submitting to ensure accuracy and completeness of information.
10. Submit the filled-out page 1 along with the rest of the required documentation to the FDA for review.

Who needs 510 k page 1?

1. Manufacturers or distributors who intend to market a medical device in the United States need to complete the 510(k) page 1.
2. It is a requirement set by the Food and Drug Administration (FDA) for premarket notification of medical devices.
3. Both companies introducing new devices to the market and those modifying existing devices are required to fill out 510(k) page 1.
4. The page 1 form provides essential information about the device, its intended use, and the submitter to the FDA for evaluation and review.

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What is 510 k page 1?

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

Who is required to file 510 k page 1?

Manufacturers of medical devices seeking FDA approval to market their device in the United States are required to file a 510(k) submission.

How to fill out 510 k page 1?

To fill out the 510(k) form, manufacturers must provide detailed information about their device, including its intended use, technological characteristics, and performance data compared to equivalent devices on the market.

What is the purpose of 510 k page 1?

The purpose of the 510(k) submission is to demonstrate the safety and effectiveness of the device being marketed by comparing it to a similar legally marketed device.

What information must be reported on 510 k page 1?

Information such as the intended use of the device, technological characteristics, summary of performance testing, comparison to similar marketed devices, and labeling must be reported on the 510(k) form.

What is the penalty for late filing of 510 k page 1?

Late filing of the 510(k) submission may result in regulatory actions, warnings, fines, or delays in market approval for the medical device.