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

    SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

    K Number: K103340 · Decision Dec 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    37
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
    K Number
    K103340
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harvest Technologies, Corp.
    Date Received
    November 15, 2010
    Decision Date
    December 6, 2010
    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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