BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

    K Number: K183205 · Decision May 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    192

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    Basic Information

    Device Name
    PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
    K Number
    K183205
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Emcyte Corporation
    Date Received
    November 19, 2018
    Decision Date
    May 30, 2019
    Product Code
    JQC
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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    Other Clearances by Emcyte Corporation

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