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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
ASSAY AND INSTRUMENT COMBINATION. 510(k) Number:
K181661
B. Purpose for Submission:
New Device
C. Measured:
BCRABL1 and ABL1 transcripts
D. Type of Test:
Reverse
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How to fill out 510k substantial equivalence determination
How to fill out 510k substantial equivalence determination
01
Start by gathering all the necessary information and documents related to the device you want to submit for substantial equivalence determination.
02
Carefully review the instructions provided by the FDA for filling out the 510k substantial equivalence determination.
03
Fill in the required information in the designated sections of the form, making sure to provide accurate and complete details.
04
Include any supporting documents or data that may be required to support your substantial equivalence determination.
05
Double-check your filled-out form and documentation for any errors or omissions.
06
Submit the completed 510k substantial equivalence determination form and all supporting documents to the FDA for review.
07
Monitor the progress of your submission and respond promptly to any requests for additional information or clarification from the FDA.
08
Await the FDA's decision on the substantial equivalence determination for your device.
Who needs 510k substantial equivalence determination?
01
Manufacturers of medical devices that are intended to be marketed in the United States need to obtain 510k substantial equivalence determination.
02
In particular, manufacturers who are introducing a new device or making significant modifications to an existing device may require a 510k substantial equivalence determination to demonstrate the safety and effectiveness of their product.
03
It is important to note that not all devices are subject to the 510k substantial equivalence determination. Some devices may fall under other regulatory pathways depending on their intended use and risk profile.
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