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

    AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328

    K Number: K933086 · Decision Oct 31, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    280
    Review Days
    495

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    Basic Information

    Device Name
    AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
    K Number
    K933086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helena Laboratories
    Date Received
    June 23, 1993
    Decision Date
    October 31, 1994
    Product Code
    JCM
    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
    JCM Control, Hemoglobin, Abnormal

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