
Emcyte Corporation
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PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System is an FDA 510(k)-cleared medical device (K183205) manufactured by Emcyte Corporation. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 29, 2019. Regulation: 8.