510(k) K183205

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System by Emcyte Corporation — Product Code JQC

K183205 is an FDA 510(k) premarket notification submitted by Emcyte Corporation for the device "PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System". The FDA issued a decision of SESU on May 30, 2019. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Emcyte Corporation has at least 1 other 510(k) clearance on record.