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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k112449 B. Purpose for Submission: New device C. Measured: Human Chorionic (HCG) D. Type of Test:

How to fill out 510k number k112449 b

How to Fill out 510k Number k112449 b:

1. Start by carefully reading the instructions provided with the form.
2. Fill out the basic information section, including your name, contact information, and the date.
3. Ensure that you have the necessary supporting documentation and include it with the form as specified.
4. Provide details about the medical device or product that you are seeking clearance for. Include information such as the intended use, specifications, and any relevant test data.
5. Describe the manufacturing process and quality control measures taken to ensure the safety and effectiveness of the device.
6. Include a thorough description of the device's components and materials used.
7. If applicable, provide information about any previous versions, modifications, or accessories related to the device.
8. Clearly state any performance standards or recognized consensus standards that are applicable to the device.
9. Include a detailed summary of any clinical data or studies conducted to support the device's safety and effectiveness.
10. Review the completed form for accuracy and completeness. Ensure that all required fields have been filled out and all necessary supporting documents have been included.

Who Needs 510k Number k112449 b:

1. Medical device manufacturers who are seeking clearance from the U.S. Food and Drug Administration (FDA) for their device.
2. Companies that have developed a new or modified medical device that falls within the scope of devices requiring a 510k clearance.
3. Healthcare professionals or researchers who are involved in the development or testing of medical devices and need to comply with FDA regulations for clearance purposes.

Please note that this information is based on general knowledge and understanding. It is always recommended to consult the official guidelines and instructions provided by the FDA or seek professional advice when filling out specific forms or seeking regulatory clearances.

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What is 510k number k112449 b?

The 510k number k112449 b is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

Who is required to file 510k number k112449 b?

The manufacturer or distributor of the medical device is required to file the 510k number k112449 b with the FDA.

How to fill out 510k number k112449 b?

To fill out 510k number k112449 b, the submitter must provide detailed information about the device, its indications for use, technological characteristics, performance data, and any relevant clinical studies.

What is the purpose of 510k number k112449 b?

The purpose of 510k number k112449 b is to demonstrate that the new device is substantially equivalent to a device already on the market and does not pose any new risks to patient health and safety.

What information must be reported on 510k number k112449 b?

The 510k number k112449 b must include information about the device design, intended use, labeling, materials, performance testing, and any clinical data supporting its safety and effectiveness.