Get May 2 22014 - Accessdata Fda

This guide provides clear instructions for completing the MAY 2 2014 - Accessdata Fda form online. By following these step-by-step directions, users can effectively submit their applications while ensuring all necessary information is accurately provided.

Follow the steps to successfully complete the form.

1. Press the ‘Get Form’ button to access the form and open it in the editor.
2. Fill in the assigned 510(k) number, which is K140426. This number is crucial for tracking the submission and should be entered accurately.
3. Provide the name of the submitting entity. In this case, input 'Centers for Disease Control and Prevention.'
4. Enter the address of the submitting entity, which is '1600 Clifton Road NE, Atlanta, GA 30333.'
5. Include the contact person's details. For this submission, input CDR Von Yu's information and their contact number: (404) 639-3046.
6. Fill in the date the document was prepared, which is 'February 14, 2014.'
7. Provide the device trade name. For this form, write 'B. anthracis Real-time PCR Assay.'
8. Specify the classification name and regulation. Here, write 'In vitro diagnostic device for Bacillus spp. detection; 21 CFR 866.3045.'
9. Enter the product code: 'NH-T.' This code is necessary for proper identification of the device.
10. Indicate the device class, which for this submission is 'II.'
11. Mention the panel relevant to the device: 'Microbiology (83).' This helps categorize the device in the right panel.
12. If applicable, provide information on predicate device(s), which in this case is 'JBAIDS Anthrax Detection System (K(051713, K(071188).' Ensure all details are correct.
13. Review all entered information for accuracy before proceeding.
14. Once all fields are completed and verified, save the changes, then proceed to download or print the form for your records.

Submit your completed document online to ensure prompt processing and compliance.