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

    SMARTPREP CENTRIFUGE SYSTEM

    K Number: K991430 · Decision May 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    37
    Applicant Total
    3
    Review Days
    32

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    Basic Information

    Device Name
    SMARTPREP CENTRIFUGE SYSTEM
    K Number
    K991430
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harvest Technologies, LLC
    Date Received
    April 26, 1999
    Decision Date
    May 28, 1999
    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 Harvest Technologies, LLC

    K Number Device Name
    K000456 HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2
    K983022 SMARTCELL PROCESSING SYSTEM