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Bundling coagulation instruments

This article was originally published in The Gray Sheet

Executive Summary

June FDA guidance on 1510(k) submissions for coagulation analyzers recommends submitting one application to FDA for "a new instrument using a new assay or reagent; a new instrument using previously cleared assay or reagent system(s); or previously cleared instrument(s) using a new assay or regent system." The guidance also covers abbreviated 510(k)s, health risks, performance characteristics, comparison studies and device labeling...
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