Get 510(k) Substantial Equivalence Determination Decision Memorandum Assay And Instrument Combination

Filling out the 510(k) Substantial Equivalence Determination Decision Memorandum Assay And Instrument Combination is an important step for demonstrating the safety and effectiveness of a new device. This guide provides clear and detailed instructions to help users navigate the online form while ensuring accuracy and compliance.

Follow the steps to successfully complete the form.

1. Press the ‘Get Form’ button to access the form and open it for editing.
2. Fill in the 510(k) number section with the appropriate identifier for your submission. This is essential for tracking and processing your application.
3. Specify the purpose for submission, indicating whether this is for a new device or another category as per your product.
4. Enter the measurand, which should detail the specific measurement you intend to monitor, in this case, International Normalized Ratio (INR).
5. Provide the type of test being used, mentioning the technological principles involved, such as electrochemical technology with amperometric detection.
6. List the name of the applicant, ensuring that it reflects the official name of the organization submitting the form.
7. Complete the proprietary and established names section, providing both the brand name and the accepted name as necessary.
8. Fill out the regulatory information section by including the regulation section, classification, product code, and relevant panels applicable to your device.
9. Clearly state the intended use of your device, ensuring that this aligns with the information included in the other sections.
10. Detail the device description, highlighting key features and components, ensuring that all necessary technical specifications are covered.
11. Provide substantial equivalence information by comparing your device with a predicate device, noting similarities and differences.
12. Include any referenced standard or guidance documents that support your submission, showcasing compliance with applicable guidelines.
13. Final review: Before submitting, check all entries for accuracy and completeness to avoid delays in processing your application.
14. Once satisfied, save your changes, and choose to download, print, or share the completed form as per your needs.

Proceed to complete your 510(k) submission online now.