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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k170079 B. Purpose for Submission: New Device C. Measured: Capillary whole blood
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To fill out the review memorandum k170079, follow these steps:
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Start by reading the k170079 document thoroughly to understand the purpose and requirements of the review.
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