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FDA 510(k), K183205, PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
FDA 510(k), K183205, PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
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510(K) Number: K183205
Device Name: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Manufacturer: Patrick Pennie
Device Classification Name: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation Number: JQC
Classification Product Code: KXA
Date Received: 11/19/2018
Decision Date: 05/30/2019
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Hematology
Device Name: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Manufacturer: Patrick Pennie
Device Classification Name: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation Number: JQC
Classification Product Code: KXA
Date Received: 11/19/2018
Decision Date: 05/30/2019
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Hematology
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