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

    GENESISCS COMPONENT CONCENTRATING SYSTEM

    K Number: K070666 · Decision Jun 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    100

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    GENESISCS COMPONENT CONCENTRATING SYSTEM
    K Number
    K070666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Perfusion Partners & Assoc., Inc.
    Date Received
    March 12, 2007
    Decision Date
    June 20, 2007
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JQC), ordered by most recent decision date.

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

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMARTPREP2 CENTRIFUGE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Perfusion Partners & Assoc., Inc.

    K Number Device Name
    K024080 SECQUIRE CELL SEPARATOR