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

    DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2

    K Number: K860784 · Decision Mar 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    6
    Review Days
    9

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    Basic Information

    Device Name
    DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
    K Number
    K860784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Tissue Culture Innovations
    Date Received
    March 3, 1986
    Decision Date
    March 12, 1986
    Product Code
    KIP
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIP Formulations, Balanced Salt Solutions

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    Other Clearances by Tissue Culture Innovations

    K Number Device Name
    K860788 HAM'S F-12 W/GLUTAMINE & NAHCO3
    K860783 MICRO CARRIER
    K860785 HAM'S F-12 W/NAHCO3
    K860786 RPMI 1640 HEPES
    K860787 DULBECCO'S MEM