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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY. 510(k) Number:
k101251
B. Purpose for Submission:
Addition of 13 new allergens to a cleared device
C. Measured:
Thirteen new allergen
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What is addition of 13 new?
Addition of 13 new refers to including 13 new items, elements, or entities.
Who is required to file addition of 13 new?
Anyone who has 13 new items, elements, or entities to report.
How to fill out addition of 13 new?
You can fill out addition of 13 new by providing the necessary information about the 13 new items.
What is the purpose of addition of 13 new?
The purpose of addition of 13 new is to keep records updated with the latest information.
What information must be reported on addition of 13 new?
It is important to report details about the 13 new items, such as their names, descriptions, and quantities.
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