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

    BIOSTRIDE FREE T4 EIA TEST KIT

    K Number: K981243 · Decision Jun 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    BIOSTRIDE FREE T4 EIA TEST KIT
    K Number
    K981243
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biostride Diagnostics, Inc.
    Date Received
    April 6, 1998
    Decision Date
    June 29, 1998
    Product Code
    CEC
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CEC Radioimmunoassay, Free Thyroxine

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