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

    IMMUNOSPOT NEONATAL T4 TEST

    K Number: K771606 · Decision Sep 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    15
    Review Days
    24

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    Basic Information

    Device Name
    IMMUNOSPOT NEONATAL T4 TEST
    K Number
    K771606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Meloy Laboratories, Inc.
    Date Received
    August 22, 1977
    Decision Date
    September 15, 1977
    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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