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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION MEMORANDUM
A. 510(k) Number:
k162430
B. Purpose for Submission:
Modification to alternative blood glucose test strips (calibration code 49) for
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What is modification to alternative blood?
Modification to alternative blood is any changes or updates made to the alternative blood product.
Who is required to file modification to alternative blood?
The manufacturer or distributor of the alternative blood product is required to file modification to alternative blood.
How to fill out modification to alternative blood?
The modification to alternative blood can be filled out electronically through the designated regulatory platform or via paper forms provided by the regulatory authority.
What is the purpose of modification to alternative blood?
The purpose of modification to alternative blood is to ensure that any changes or updates to the alternative blood product are properly documented and reviewed by the regulatory authority.
What information must be reported on modification to alternative blood?
The modification to alternative blood should include details of the changes or updates made to the alternative blood product, along with any supporting data or documentation.
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