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

    DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)

    K Number: K883273 · Decision Sep 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    261
    Applicant Total
    280
    Review Days
    35

    Basic Information

    Device Name
    DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
    K Number
    K883273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    3M COMPANY
    Date Received
    August 3, 1988
    Decision Date
    September 7, 1988
    Product Code
    DHB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DHB System, Test, Radioallergosorbent (Rast) Immunological

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