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

    IMMUCHEM COVALENT COAT SOLID PHASE ASSAY

    K Number: K791664 · Decision Sep 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    18
    Review Days
    37

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    Basic Information

    Device Name
    IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
    K Number
    K791664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Immuchem Corp.
    Date Received
    August 21, 1979
    Decision Date
    September 27, 1979
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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    K860559 ANDROSTENEDIONE 125I KIT BY RIA
    K854094 IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
    K830962 IMMUCHEM COVALENT-COAT RIA KIT
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