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

    SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT

    K Number: K872847 · Decision Aug 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    21

    Basic Information

    Device Name
    SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
    K Number
    K872847
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2800
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    CANDACE LANE CORP.
    Date Received
    July 20, 1987
    Decision Date
    August 10, 1987
    Product Code
    KIS
    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
    KIS Sera, Animal And Human

    Similar 510(k) Clearances

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

    ANIMAL AND HUMAN SERA

    FDA 510(k)
    FDA Class 1 ·Hematology

    BOVINE CALF SERUM SUPPLEMENTED #A-2159

    FDA 510(k)
    FDA Class 1 ·Hematology

    BOVINE CALF SERUM CATALOG #A-2119

    FDA 510(k)
    FDA Class 1 ·Hematology

    MLC NORMAL SERUM

    FDA 510(k)
    FDA Class 1 ·Hematology

    FETAL BOVINE SERUM

    FDA 510(k)
    FDA Class 1 ·Hematology

    ADULT BOVINE SERUM

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all