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

    BTC URINE LCG ASSAY

    K Number: K831125 · Decision May 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    BTC URINE LCG ASSAY
    K Number
    K831125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Btc Diagnostics, Inc.
    Date Received
    April 5, 1983
    Decision Date
    May 5, 1983
    Product Code
    JHJ
    Advisory Committee
    Clinical Chemistry
    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
    JHJ Agglutination Method, Human Chorionic Gonadotropin

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    Other Clearances by Btc Diagnostics, Inc.

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