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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
k160682
B. Purpose for Submission:
New device
C. Measured:
Glucose in fresh
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01
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02
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03
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04
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05
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06
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07
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08
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09
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01
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What is review memorandum k160682?
Review memorandum k160682 is a document that summarizes the findings and decisions made during a review process.
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Review memorandum k160682 should be filled out by providing all relevant information and details related to the review process.
What is the purpose of review memorandum k160682?
The purpose of review memorandum k160682 is to document the review process, findings, and decisions for future reference.
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Information such as review process details, findings, decisions, and any relevant supporting documentation must be reported on review memorandum k160682.
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