BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION

    K Number: K813342 · Decision Mar 4, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    21
    Review Days
    99

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    Basic Information

    Device Name
    GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
    K Number
    K813342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Gamma Biologicals, Inc.
    Date Received
    November 25, 1981
    Decision Date
    March 4, 1982
    Product Code
    KSK
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KSK Solution, Stabilized Enzyme

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