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

    INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

    K Number: K040146 · Decision May 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    4
    Review Days
    103

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    Basic Information

    Device Name
    INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K Number
    K040146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interlab S.R.L.
    Date Received
    January 22, 2004
    Decision Date
    May 4, 2004
    Product Code
    GKA
    Advisory Committee
    Hematology
    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
    GKA Abnormal Hemoglobin Quantitation

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    Other Clearances by Interlab S.R.L.

    K Number Device Name
    K053571 MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K032862 INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K033187 INTERLAB IMMUNOFIXATION TEST(S)