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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k070239
B. Purpose for Submission:
New Device
C. Measured:
Whole blood glucose
D.
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Who needs form 510k program evaluating?
01
Medical device manufacturers who are seeking FDA approval for their new medical devices.
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What is form 510k program evaluating?
Form 510k program evaluates the safety and effectiveness of medical devices.
Who is required to file form 510k program evaluating?
Manufacturers of medical devices are required to file form 510k program.
How to fill out form 510k program evaluating?
Form 510k program can be filled out online through the FDA website.
What is the purpose of form 510k program evaluating?
The purpose of form 510k program is to demonstrate that a medical device is substantially equivalent to a device that is already legally marketed.
What information must be reported on form 510k program evaluating?
Information on device classification, design, performance, and intended use must be reported on form 510k program.
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