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

    H-FLU B ELISA TEST

    K Number: K831525 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    20
    Review Days
    140

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    Basic Information

    Device Name
    H-FLU B ELISA TEST
    K Number
    K831525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Seragen Diagnostics, Inc.
    Date Received
    May 12, 1983
    Decision Date
    September 29, 1983
    Product Code
    GRP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GRP Antisera, All Types, H. Influenza

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