Tips For Obtaining Your 510(k) FDA Clearance

Med Device Online

By Rolland Carlson, Ph.D., CEO, Immunexpress Our SeptiCyte RAPID clinical test received 510(k) FDA clearance indicated for the diagnosis of sepsis in adults. Sepsis is a life-threatening medical condition. Every minute counts for these patients in the ER and ICU. Clinicians in these settings need processes to distinguish sepsis patients from infection-negative systemic inflammation and…

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