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

    GLUCOSE-6-PHOSPHATE DEHYDROGENASE

    K Number: K823900 · Decision Feb 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    39

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    Basic Information

    Device Name
    GLUCOSE-6-PHOSPHATE DEHYDROGENASE
    K Number
    K823900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7360
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Alladin Diagnostic, Inc.
    Date Received
    December 30, 1982
    Decision Date
    February 7, 1983
    Product Code
    KQE
    Advisory Committee
    Hematology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KQE Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase

    Other Clearances by Alladin Diagnostic, Inc.

    K Number Device Name
    K844965 LEUCINE AMINOPEPTIDASE REAGENT