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We note that if Septicyte RAPID is substantially similar to SeptiCyte LAB, we believe the newness period for this technology would begin on April 6, 2017 with the 510(k) approval date for SeptiCyte LAB and, therefore, because the 3-year anniversary date of the technology's entry onto the U.S

Bhattacherjee A, Chakraborti AS (2011) Fructose-induced modifications of myoglobin: change of structure from met (Fe3+) to oxy (Fe2+) form

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